A newfangled study using risk silhouette and uncertainty approximation for quantification of acyclovir in diverse formulation

Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results.Additionally,there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product.In the present work,evaluation of risk profile,combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied.Uncertainty was calculated using cause-effect approach,and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines.While assessing the results of validation,the calibration model was justified by the lack of fit and Levene＇s test.Risk profile represents the future applications of this method.In uncertainty the major contribution is due to sample concentration and mass.This work demonstrates the application of theoretical concepts of calibration model tests,relative bias,risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.

Measurement Uncertainty Assessment of Magnesium Trisilicate Column for Determination of Sudan Colorants in Food by HPLC Using C8 Column

This study aimed to conduct measurement uncertainty assessment of a new method for determination of Sudan colorants（Sudan Ⅰ, Ⅱ, Ⅲ and Ⅳ） in food by high performance liquid chromatography（HPLC）. Samples were extracted with organic solvents（hexane, 20% acetone） and first purified by magnesium trisilicate（2Mg O·3Si O2）. The Sudan colorants（Sudan Ⅰ–Ⅳ） were also initially separated on C8 by gradient elution using acetonitrile and 0.1%（v/v） formic acid aqueous solution as the mobile phases and detected with diode-array detector（DAD）. The uncertainty of mathematical model of Sudan Ⅰ, Ⅱ, Ⅲ, Ⅳ is based on EURACHEM guidelines. The sources and components of uncertainty were calculated. The experiment gave a good linear relationship over the concentration from 0.4 to 4.0 μg/m L and spiked recoveries were from 74.0% to 97.5%. The limits of determination（LOD） were 48, 61, 36, 58 μg/kg for the four analytes, respectively. The total uncertainty of Sudan colorants（Sudan Ⅰ, Ⅱ, Ⅲ and Ⅳ） was 810±30.8, 790±28.4, 750±27.0, 730±50.0 μg/kg, respectively. The recovery uncertainty was the most significant factor contributing to the total uncertainty. The developed method is simple, rapid, and highly sensitive. It can be used for the determination of trace Sudan dyes in food samples. The sources of uncertainty have been identified and uncertainty components have been simplified and considered.

Fuzzy norm method for evaluating random vibration of airborne platform from limited PSD data

For random vibration of airborne platform, the accurate evaluation is a key indicator to ensure normal operation of airborne equipment in flight. However, only limited power spectral density（PSD） data can be obtained at the stage of flight test. Thus, those conventional evaluation methods cannot be employed when the distribution characteristics and priori information are unknown. In this paper, the fuzzy norm method（FNM） is proposed which combines the advantages of fuzzy theory and norm theory. The proposed method can deeply dig system information from limited data, which probability distribution is not taken into account. Firstly, the FNM is employed to evaluate variable interval and expanded uncertainty from limited PSD data, and the performance of FNM is demonstrated by confidence level, reliability and computing accuracy of expanded uncertainty. In addition, the optimal fuzzy parameters are discussed to meet the requirements of aviation standards and metrological practice. Finally, computer simulation is used to prove the adaptability of FNM. Compared with statistical methods, FNM has superiority for evaluating expanded uncertainty from limited data. The results show that the reliability of calculation and evaluation is superior to 95%.