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Enantioselective analytical methods in chiral drug metabolism
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作者 洪燕君 高凌波 曾苏 《Journal of Chinese Pharmaceutical Sciences》 CAS 2008年第3期177-182,共6页
The chiral nature of biological systems enables their stereoselective interaction with chiral compounds. It has been well documented that the enantiomers ofa chiral drug may show differences in drug disposition especi... The chiral nature of biological systems enables their stereoselective interaction with chiral compounds. It has been well documented that the enantiomers ofa chiral drug may show differences in drug disposition especially in metabolic behavior. As a result, it is of vital importance to separate the enantiomers of a chiral drug in metabolic studies. This paper discusses enantioselective methods (include high-performance liquid chromatography, gas chromatography, capillary electrophoresis and high-performance liquid chromatography-mass spectrometry) that applied in chiral drug metabolism, using most recent examples where possible. 展开更多
关键词 Enantioselective analytical methods Chiral drug Drug metabolism
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Analytical Method for the Wave Diffraction of Asymmetrically Arranged Breakwaters
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作者 ZHOU Pei-xin ZHANG Hong-sheng 《China Ocean Engineering》 SCIE EI CSCD 2024年第5期797-808,共12页
The layout forms of several breakwater structures can be generalized as asymmetrical arrangements in actual engineering.However,the problem of wave diffraction around asymmetrically arranged breakwaters has not been a... The layout forms of several breakwater structures can be generalized as asymmetrical arrangements in actual engineering.However,the problem of wave diffraction around asymmetrically arranged breakwaters has not been adequately investigated.In this study,we propose an analytical method of wave diffraction for regular waves passing through asymmetrically arranged breakwaters,and we use the Nyström method to obtain the analytical solution numerically.We compared the results of this method with those of previous analytical solutions and with numerical results to demonstrate the validity of our approach.We also provided diffraction coefficient diagrams of breakwaters with different layout forms.Moreover,we described the analytical expression for the problem of diffraction through long-wave incident breakwaters and presented an analysis of the relationship between the diffraction coefficients and the widths of breakwater gates.The analytical method presented in this study contributes to the limited literature on the theory of wave diffraction through asymmetrically arranged breakwaters. 展开更多
关键词 regular waves BREAKWATERS analytical method wave diffraction
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Utility and Application of a Versatile Analytical Method for MMF Calculation in AC Machines
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作者 Ze-Zheng Wu Robert Nilssen Jian-Xin Shen 《CES Transactions on Electrical Machines and Systems》 EI CSCD 2024年第1期22-31,共10页
A versatile analytical method(VAM) for calculating the harmonic components of the magnetomotive force(MMF) generated by diverse armature windings in AC machines has been proposed, and the versatility of this method ha... A versatile analytical method(VAM) for calculating the harmonic components of the magnetomotive force(MMF) generated by diverse armature windings in AC machines has been proposed, and the versatility of this method has been established in early literature. However, its practical applications and significance in advancing the analysis of AC machines need further elaboration. This paper aims to complement VAM by augmenting its theory, offering additional insights into its conclusions, as well as demonstrating its utility in assessing armature windings and its application of calculating torque for permanent magnet synchronous machines(PMSM). This work contributes to advancing the analysis of AC machines and underscores the potential for improved design and performance optimization. 展开更多
关键词 AC machine analytical method Harmonic analysis MMF Magnetic field Torque calculation
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Structural Modal Parameter Recognition and Related Damage Identification Methods under Environmental Excitations: A Review
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作者 Chao Zhang Shang-Xi Lai Hua-Ping Wang 《Structural Durability & Health Monitoring》 EI 2025年第1期25-54,共30页
Modal parameters can accurately characterize the structural dynamic properties and assess the physical state of the structure.Therefore,it is particularly significant to identify the structural modal parameters accordi... Modal parameters can accurately characterize the structural dynamic properties and assess the physical state of the structure.Therefore,it is particularly significant to identify the structural modal parameters according to the monitoring data information in the structural health monitoring(SHM)system,so as to provide a scientific basis for structural damage identification and dynamic model modification.In view of this,this paper reviews methods for identifying structural modal parameters under environmental excitation and briefly describes how to identify structural damages based on the derived modal parameters.The paper primarily introduces data-driven modal parameter recognition methods(e.g.,time-domain,frequency-domain,and time-frequency-domain methods,etc.),briefly describes damage identification methods based on the variations of modal parameters(e.g.,natural frequency,modal shapes,and curvature modal shapes,etc.)and modal validation methods(e.g.,Stability Diagram and Modal Assurance Criterion,etc.).The current status of the application of artificial intelligence(AI)methods in the direction of modal parameter recognition and damage identification is further discussed.Based on the pre-vious analysis,the main development trends of structural modal parameter recognition and damage identification methods are given to provide scientific references for the optimized design and functional upgrading of SHM systems. 展开更多
关键词 Structural health monitoring data information modal parameters damage identification AI method
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A coupled Legendre-Laguerre polynomial method with analytical integration for the Rayleigh waves in a quasicrystal layered half-space with an imperfect interface
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作者 Bo ZHANG Honghang TU +2 位作者 Weiqiu CHEN Jiangong YU L.ELMAIMOUNI 《Applied Mathematics and Mechanics(English Edition)》 SCIE EI CSCD 2024年第9期1539-1556,共18页
The Laguerre polynomial method has been successfully used to investigate the dynamic responses of a half-space.However,it fails to obtain the correct stress at the interfaces in a layered half-space,especially when th... The Laguerre polynomial method has been successfully used to investigate the dynamic responses of a half-space.However,it fails to obtain the correct stress at the interfaces in a layered half-space,especially when there are significant differences in material properties.Therefore,a coupled Legendre-Laguerre polynomial method with analytical integration is proposed.The Rayleigh waves in a one-dimensional(1D)hexagonal quasicrystal(QC)layered half-space with an imperfect interface are investigated.The correctness is validated by comparison with available results.Its computation efficiency is analyzed.The dispersion curves of the phase velocity,displacement distributions,and stress distributions are illustrated.The effects of the phonon-phason coupling and imperfect interface coefficients on the wave characteristics are investigated.Some novel findings reveal that the proposed method is highly efficient for addressing the Rayleigh waves in a QC layered half-space.It can save over 99%of the computation time.This method can be expanded to investigate waves in various layered half-spaces,including earth-layered media and surface acoustic wave(SAW)devices. 展开更多
关键词 coupled Legendre-Laguerre polynomial method analytical integration Rayleigh wave quasicrystal(QC)layered half-space imperfect interface
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Robustness Study and Superior Method Development and Validation for Analytical Assay Method of Atropine Sulfate in Pharmaceutical Ophthalmic Solution
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作者 Md. Nazmus Sakib Chowdhury Sreekanta Nath Dalal +4 位作者 Md. Ariful Islam Md. Anwar Hossain Pranab Kumar Das Shakawat Hossain Parajit Das 《American Journal of Analytical Chemistry》 CAS 2024年第5期151-164,共14页
Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical ... Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%. 展开更多
关键词 ROBUSTNESS method Validation HPLC Compendial method method Development GDP LOQ
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Development of analytical methods for polycyclic aromatic hydrocarbons (PAHs) in airborne particulates: A review 被引量:10
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作者 LIU Li-bin LIU Yan +3 位作者 LIN Jin-ming TANG Ning HAYAKAWA Kazuichi MAEDA Tsuneaki 《Journal of Environmental Sciences》 SCIE EI CAS CSCD 2007年第1期1-11,共11页
In the present work, the different sample collection, pretreatment and analytical methods for polycyclic aromatic hydrocarbons (PAHs) in airborne particulates is systematacially reviewed, and the applications of the... In the present work, the different sample collection, pretreatment and analytical methods for polycyclic aromatic hydrocarbons (PAHs) in airborne particulates is systematacially reviewed, and the applications of these pretreatment and analytical methods for PAHs are compared in detail. Some comments on the future expectation are also presented. 展开更多
关键词 polycyclic aromatic hydrocarbons (PAHs) airborne particulates analytical methods REVIEW
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Methods of analytical mechanics for solving differential equations of first order 被引量:5
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作者 吴惠彬 梅凤翔 《Chinese Physics B》 SCIE EI CAS CSCD 2005年第12期2391-2394,共4页
A differential equation of first order can be expressed by the equation of motion of a mechanical system. In this paper, three methods of analytical mechanics, i.e. the Hamilton-Noether method, the Lagrange-Noether me... A differential equation of first order can be expressed by the equation of motion of a mechanical system. In this paper, three methods of analytical mechanics, i.e. the Hamilton-Noether method, the Lagrange-Noether method and the Poisson method, are given to solve a differential equation of first order, of which the way may be called the mechanical methodology in mathematics. 展开更多
关键词 analytical mechanics differential equation Noether theory Poisson method
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Analytical methods for investigating in vivo fate of nanoliposomes:A review 被引量:5
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作者 Chong Su Yingze Liu +1 位作者 Yang He Jingkai Gu 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2018年第4期219-225,共7页
Nanoliposomes are considered to be the most successful nanoparticle drug delivery system, but their fate in vivo has not been fully understood due to lack of reliable bioanalytical methods, which seriously limits the ... Nanoliposomes are considered to be the most successful nanoparticle drug delivery system, but their fate in vivo has not been fully understood due to lack of reliable bioanalytical methods, which seriously limits the development of liposomal drugs. Hence, an overview of currently used bioanalytical methods is imperative to lay the groundwork for the need of developing a bioanalytical method for liposome measurements in vivo. Currently, major analytical methods for nanoliposomes measurement in vivo include fluorescence labeling, radiolabeling, magnetic resonance imaging(MRI), mass spectrometry and computed tomography. In this review, these bioanalytical methods are summarized, and the advantages and disadvantages of each are discussed. We provide insights into the applicability and limitations of these analytical methods in the application of nanoliposomes measurement in vivo, and highlight the recent development of instrumental analysis techniques. The review is devoted to providing a comprehensive overview of the investigation of nanoliposomes design and associated fate in vivo, promoting the development of bioanalytical techniques for nanoliposomes measurement, and understanding the pharmacokinetic behavior, effectiveness and potential toxicity of nanoliposomes in vivo. 展开更多
关键词 Liposomes analytical methods In vivo fate Liposomal drug
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Analytical methods for determination of terbinafine hydrochloride in pharmaceuticals and biological materials 被引量:2
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作者 Basavaiah Kanakapura Vamsi Krishna Penmatsa 《Journal of Pharmaceutical Analysis》 SCIE CAS 2016年第3期137-149,共13页
Terbinafine is a new powerful antifungal agent indicated for both oral and topical treatment of myco- sessince. It is highly effective in the treatment of determatomycoses. The chemical and pharmaceutical analysis of ... Terbinafine is a new powerful antifungal agent indicated for both oral and topical treatment of myco- sessince. It is highly effective in the treatment of determatomycoses. The chemical and pharmaceutical analysis of the drug requires effective analytical methods for quality control and pharmacodynamic and pharmacokinetic studies. Ever since it was introduced as an effective antifungal agent, many methods have been developed and validated for its assay in pharmaceuticals and biological materials. This article reviews the various methods reported during the last 25 years. 展开更多
关键词 Terbinafine hydrochloride analytical methods Pharmaceuticals Biological materials
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Analytical Methods for Environmental Risk Assessment of Acid Sulfate Soils: A Review 被引量:5
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作者 C. LIN School of Environmental Science and Management, Southern Cross University, Lismore, NSW (Australia) 《Pedosphere》 SCIE CAS CSCD 2001年第4期301-310,共10页
Assessment of acid sulfate soil risk is an important step for acid sulfate soil management and its reliability depends very much on the suitability and accuracy of various analytical methods for estimating sulfide-der... Assessment of acid sulfate soil risk is an important step for acid sulfate soil management and its reliability depends very much on the suitability and accuracy of various analytical methods for estimating sulfide-derived potential acidity, actual acidity and acid-neutralizing capacity in acid sulfate soils. This paper critically reviews various analytical methods that are currently used for determination of the above parameters, as well as their implications for environmental risk assessment of acid sulfate soi1s. 展开更多
关键词 acid risk assessment acid sulfate soils analytical methods
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Pioglitazone:A review of analytical methods 被引量:2
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作者 N.Satheeshkumar S.Shantikumar R.Srinivas 《Journal of Pharmaceutical Analysis》 SCIE CAS 2014年第5期295-302,共8页
Pioglitazone is an oral anti-hyperglycemic agent. It is used for the treatment of diabetes mellitus type 2. It selectively stimulates nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-gamma). I... Pioglitazone is an oral anti-hyperglycemic agent. It is used for the treatment of diabetes mellitus type 2. It selectively stimulates nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-gamma). It was the tenth-best-selling drug in the U.S. in 2008. This article examines published analytical methods reported so far in the literature for the determination of pioglitazone in biological samples and pharmaceutical formulations. They include various techniques like electrochemical methods, spectrophotometry, capillary electrophoresis, high-performance liquid chromatography, liquid chromatography-electrospray ionization-tandem mass spectrometry and high-performance thin layer chromatography. 展开更多
关键词 PIOGLITAZONE analytical methods Diabetes mellitus type 2
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A new analytical model for thermal stresses in multi-phase materials and lifetime prediction methods 被引量:3
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作者 Ladislav Ceniga 《Acta Mechanica Sinica》 SCIE EI CAS CSCD 2008年第2期189-206,共18页
Based on the fundamental equations of the mechanics of solid continuum, the paper employs an analytical model for determination of elastic thermal stresses in isotropic continuum represented by periodically distribute... Based on the fundamental equations of the mechanics of solid continuum, the paper employs an analytical model for determination of elastic thermal stresses in isotropic continuum represented by periodically distributed spherical particles with different distributions in an infinite matrix, imaginarily divided into identical cells with dimensions equal to inter-particle distances, containing a central spherical particle with or without a spherical envelope on the particle surface. Consequently, the multi-particle-(envelope)- matrix system, as a model system regarding the analytical modelling, is applicable to four types of multi-phase materials. As functions of the particle volume fraction v, the inter-particle distances dl, d2, d3 along three mutually per- pendicular axes, and the particle and envelope radii, R1 and R2, respectively, the thermal stresses within the cell, are originated during a cooling process as a consequence of the difference in thermal expansion coefficients of phases rep- resented by the matrix, envelope and particle. Analytical-(experimental)-computational lifetime prediction methods for multi-phase materials are proposed, which can be used in engineering with appropriate values of parameters of real multi-phase materials. 展开更多
关键词 Thermal stress Multi-phase material Lifetime prediction analytical modelling
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Analytical mechanics methods for solving Whittaker equations 被引量:3
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作者 梅凤翔 解加芳 江铁强 《Chinese Physics B》 SCIE EI CAS CSCD 2007年第10期2845-2847,共3页
The purpose of this paper is to study the solution of the celebrated Whittaker equations by using analytical mechanics methods, including the Lagrange-Noether method, Hamilton-Poisson method and potential integral met... The purpose of this paper is to study the solution of the celebrated Whittaker equations by using analytical mechanics methods, including the Lagrange-Noether method, Hamilton-Poisson method and potential integral method. 展开更多
关键词 Whittaker equations Lagrange-Noether method Hamilton-Poisson method potential integral method
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Comparative Analysis of Tunnel Seepage Field under Different Waterproof and Drainage System Using Analytical Methods 被引量:5
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作者 Serges Mendomo Meye Zhenzhong Shen 《Engineering(科研)》 2020年第6期401-423,共23页
Tunnel seepage is an important factor affecting the progress and safety of tunnel construction. In this paper, the mining method tunnel construction in the water-rich weathered granite stratum is taken as the research... Tunnel seepage is an important factor affecting the progress and safety of tunnel construction. In this paper, the mining method tunnel construction in the water-rich weathered granite stratum is taken as the research object. Through the analytical calculation method, the distribution law of tunnel seepage field under different waterproof and drainage types is studied, and the comparative analysis is carried out. According to the analytical solution, the influencing factors of grouting parameters are proposed. The sensitivity of the tunnel seepage field to the variation of grouting parameters is analyzed. A novel waterproof and drainage system, and construction technology suitable for subway tunnels with large buried depth below groundwater level were proposed. 展开更多
关键词 Seepage Field WATERPROOF analytical Solutions TUNNEL Controlled Drainage
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Analysis profile of the fully grouted rock bolt in jointed rock using analytical and numerical methods 被引量:4
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作者 Ghadimi Mostafa Shahriar Kourosh Jalalifar Hossein 《International Journal of Mining Science and Technology》 SCIE EI 2014年第5期609-615,共7页
The purpose of this study was to investigate the effect of bolt profile on load transfer mechanism of fully grouted bolts in jointed rocks using analytical and numerical methods. Based on the analytical method with de... The purpose of this study was to investigate the effect of bolt profile on load transfer mechanism of fully grouted bolts in jointed rocks using analytical and numerical methods. Based on the analytical method with development of methods, a new model is presented. To validate the analytical model, five different profiles modeled by ANSYS software. The profile of rock bolts T3 and T4with load transfer capacity,respectively 180 and 195 kN in the jointed rocks was selected as the optimum profiles. Finally, the selected profiles were examined in Tabas Coal Mine. FLAC analysis indicates that patterns 6+7 with2 NO flexi bolt 4 m better than other patterns within the faulted zone. 展开更多
关键词 Fully grouted bolt Load transfer mechanism Jointed rocks analytical and numerical methods
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New analytical exact solutions of time fractional KdV KZK equation by Kudryashov methods 被引量:4
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作者 S Saha Ray 《Chinese Physics B》 SCIE EI CAS CSCD 2016年第4期30-36,共7页
In this paper, new exact solutions of the time fractional KdV-Khokhlov-Zabolotskaya-Kuznetsov (KdV-KZK) equa- tion are obtained by the classical Kudryashov method and modified Kudryashov method respectively. For thi... In this paper, new exact solutions of the time fractional KdV-Khokhlov-Zabolotskaya-Kuznetsov (KdV-KZK) equa- tion are obtained by the classical Kudryashov method and modified Kudryashov method respectively. For this purpose, the modified Riemann-Liouville derivative is used to convert the nonlinear time fractional KdV-KZK equation into the non- linear ordinary differential equation. In the present analysis, the classical Kudryashov method and modified Kudryashov method are both used successively to compute the analytical solutions of the time fractional KdV-KZK equation. As a result, new exact solutions involving the symmetrical Fibonacci function, hyperbolic function and exponential function are obtained for the first time. The methods under consideration are reliable and efficient, and can be used as an alternative to establish new exact solutions of different types of fractional differential equations arising from mathematical physics. The obtained results are exhibited graphically in order to demonstrate the efficiencies and applicabilities of these proposed methods of solving the nonlinear time fractional KdV-KZK equation. 展开更多
关键词 KdV-Khokhlov-Zabolotskaya-Kuznetsov equation Kudryashov method modified Kudryashovmethod fractional complex transform modified Riemann-Liouville derivative
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Evaluation of Rainwater Harvesting Methods and Structures Using Analytical Hierarchy Process for a Large Scale Industrial Area 被引量:1
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作者 V. JOTHIPRAKASH Mandar V. SATHE 《Journal of Water Resource and Protection》 2009年第6期427-438,共12页
In India, with ever increasing population and stress on natural resources, especially water, rejuvenation of rainwater harvesting (RWH) technique which was forgotten over the days is becoming very essential. Large num... In India, with ever increasing population and stress on natural resources, especially water, rejuvenation of rainwater harvesting (RWH) technique which was forgotten over the days is becoming very essential. Large number of RWH methods that are available in the literature are demand specific and site specific, since RWH system depends on the topography, land use, land cover, rainfall and demand pattern. Thus for each and every case, a detailed evaluation of RWH structures is required for implementation, including the analy-sis of hydrology, topography and other aspects like site availability and economics, however a common methodology could be evolved. The present study was aimed at evaluation of various RWH techniques in order to identify the most appropriate technique suitable for a large scale industrial area to meet its daily wa-ter demand. An attempt is made to determine the volume of water to be stored using mass balance method, Ripple diagram method, analytical method, and sequent peak algorithm method. Based on various satisfying criteria, analytical hierarchy process (AHP) is employed to determine the most appropriate type of RWH method and required number of RWH structures in the study area. If economy alone is considered along with hydrological and site specific parameters, recharging the aquifer has resulted as a better choice. However other criteria namely risk, satisfaction in obtaining required volume of water for immediate utilization etc. has resulted in opting for concrete storage structures method. From the results it is found that AHP, if used with all possible criteria can result in a better tool for evaluation of RWH methods and structures. This RWH structures not only meets the demand but saves transportation cost of water and reduces the dependability of the industry on irrigation reservoir. Besides monetary benefits it is hoped that the micro environment inside the industry will improve due to the cooling effect of the stored water. 展开更多
关键词 RAIN Water HARVESTING analytical HIERARCHY Process Large SCALE Industrial Area AQUIFER
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Research on Slope Movement and Landslide by Methods of Analytical Geomechanics
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《Journal of Earth Science》 SCIE CAS CSCD 1997年第2期52-56,共5页
ResearchonSlopeMovementandLandslidebyMethodsofAnalyticalGeomechanics*YanTongzhenYuHongmingWangJianfengFacult... ResearchonSlopeMovementandLandslidebyMethodsofAnalyticalGeomechanics*YanTongzhenYuHongmingWangJianfengFacultyofEnvironmentalS... 展开更多
关键词 LANDSLIDE methods analytical
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Analytical Method Development and Validation of Filgrastim by UV and RP-UFLC Methods 被引量:1
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作者 Husna Kanwal Qureshi Ciddi Veeresham Chinta Srinivas 《American Journal of Analytical Chemistry》 2021年第10期333-346,共14页
The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar... The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The <i>λ</i><sub>max</sub> of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines. 展开更多
关键词 BIOSIMILARS Filgastim method Development RP-UFLC UV Visible Spectroscopy VALIDATION
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