A rapid, straightforward, sensitive, efficient, and cost-effective reverse-phase high-performance liquid chromatographic method was employed for the simultaneous determination of Sorbitol, Sodium Lactate, and Chloride...A rapid, straightforward, sensitive, efficient, and cost-effective reverse-phase high-performance liquid chromatographic method was employed for the simultaneous determination of Sorbitol, Sodium Lactate, and Chlorides in a drug solution for infusion. Sorbitol, Sodium lactate, and Chloride are all officially recognized in the USP monograph. Assay methods are provided through various techniques, with titrations being ineffective for trace-level quantification. Alternatively, IC, AAS, and ICP-MS, though highly accurate, are costly and often unavailable to most testing facilities. When considering methods, it’s important to prioritize both quality control requirements and user-friendly techniques. A simple HPLC simultaneous method was developed for the quantification of Chlorides, Sorbitol, and Sodium Lactate with a shorter run time. The separation utilized a Shimpack SCR-102(H) ion exclusion analytical column (7.9 mm × 300 mm, 7 μm), with a flow rate of 0.6 mL per min. The column compartment temperature was maintained at 40°C, and the injection volume was set at 10 μL, with detection at 200 nm. All measurements were conducted in a 0.1% solution of phosphoric acid. The analytical curves demonstrated linearity (r > 0.9999) in the concentration range of 0.79 to 3.8 mg per mL for Sodium Lactate (SL), 0.16 to 0.79 mg per mL for Sodium Chloride (SC), and 1.5 to 7.2 mg per mL for Sorbitol. Validation of the developed method followed the guidelines of the International Conference on Harmonization (ICH Q2B) and USP. The method exhibited precision, robustness, accuracy, and selectivity. In accelerated stability testing over 6 months, no significant variations were observed in organoleptic analysis and pH. Consequently, the developed method is deemed suitable for routine quality control analyses, enabling the simultaneous determination of Sodium Lactate, Sodium Chloride, and Sorbitol in pharmaceutical formulations and infusions.展开更多
[Objective] The paper aimed to provide a basis for quality control of compound sulfamonomethoxine sodium propolis solution. [Method] High per- formance liquid chromatography （HPLC） method was used to determine the c...[Objective] The paper aimed to provide a basis for quality control of compound sulfamonomethoxine sodium propolis solution. [Method] High per- formance liquid chromatography （HPLC） method was used to determine the contents of sulfamonomethoxine sodium and trimethoprim simultaneously in compound sulfamonomethoxine sodium propolis solution. [Result] Sulfamonomethoxine sodium and trimethoprim showed a linear relationship within the concentration of 10 - 500 μg/mL under the following chromatographic conditions： Kromasil C18 column （250 mm × 4.6 mm, 5 μm）, mobile phase 0.02 mol/L phosphoric acid solution- methanol（80：20, V/V）, detection wavelength 270 nm, flow rate 1.0 mL/min, and column temperature 30℃. The average recoveries were 99.3% and 99.4%, respectively. [ Conclusion] The method is accurate and feasible, and can determine sulfamonomethoxine sodium and trimethoprim simultaneously in compound sul- famonomethoxine sodium propolis solution.展开更多
A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Monteluka...A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Montelukast Sodium (MON) and Desloratadine (DES) in pharmaceutical dosage forms. The drugs were estimated using Hypersil BDS C18 (250 mm × 4.6 mm I.D., 5 μ particle size) column. The mobile phase composed of orthophosphoric acid and water in the ratio of 20:80 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 280 nm. The linearity range obtained was 10 - 30 μg/ml for MON and 5 - 15 μg/ml for DES with retention times of 2.929 min and 4.439 min for MON and DES respectively. The correlation coefficient values were found to be 0.999. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of MON and DES were in the range of 99.59% - 99.82% and 99.60% - 99.80% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.176 μg/ml, 0.587 μg/ml for MON and 0.087 μg/ml, 0.292 μg/ml for DES respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available tablet dosage forms.展开更多
文摘A rapid, straightforward, sensitive, efficient, and cost-effective reverse-phase high-performance liquid chromatographic method was employed for the simultaneous determination of Sorbitol, Sodium Lactate, and Chlorides in a drug solution for infusion. Sorbitol, Sodium lactate, and Chloride are all officially recognized in the USP monograph. Assay methods are provided through various techniques, with titrations being ineffective for trace-level quantification. Alternatively, IC, AAS, and ICP-MS, though highly accurate, are costly and often unavailable to most testing facilities. When considering methods, it’s important to prioritize both quality control requirements and user-friendly techniques. A simple HPLC simultaneous method was developed for the quantification of Chlorides, Sorbitol, and Sodium Lactate with a shorter run time. The separation utilized a Shimpack SCR-102(H) ion exclusion analytical column (7.9 mm × 300 mm, 7 μm), with a flow rate of 0.6 mL per min. The column compartment temperature was maintained at 40°C, and the injection volume was set at 10 μL, with detection at 200 nm. All measurements were conducted in a 0.1% solution of phosphoric acid. The analytical curves demonstrated linearity (r > 0.9999) in the concentration range of 0.79 to 3.8 mg per mL for Sodium Lactate (SL), 0.16 to 0.79 mg per mL for Sodium Chloride (SC), and 1.5 to 7.2 mg per mL for Sorbitol. Validation of the developed method followed the guidelines of the International Conference on Harmonization (ICH Q2B) and USP. The method exhibited precision, robustness, accuracy, and selectivity. In accelerated stability testing over 6 months, no significant variations were observed in organoleptic analysis and pH. Consequently, the developed method is deemed suitable for routine quality control analyses, enabling the simultaneous determination of Sodium Lactate, Sodium Chloride, and Sorbitol in pharmaceutical formulations and infusions.
文摘[Objective] The paper aimed to provide a basis for quality control of compound sulfamonomethoxine sodium propolis solution. [Method] High per- formance liquid chromatography （HPLC） method was used to determine the contents of sulfamonomethoxine sodium and trimethoprim simultaneously in compound sulfamonomethoxine sodium propolis solution. [Result] Sulfamonomethoxine sodium and trimethoprim showed a linear relationship within the concentration of 10 - 500 μg/mL under the following chromatographic conditions： Kromasil C18 column （250 mm × 4.6 mm, 5 μm）, mobile phase 0.02 mol/L phosphoric acid solution- methanol（80：20, V/V）, detection wavelength 270 nm, flow rate 1.0 mL/min, and column temperature 30℃. The average recoveries were 99.3% and 99.4%, respectively. [ Conclusion] The method is accurate and feasible, and can determine sulfamonomethoxine sodium and trimethoprim simultaneously in compound sul- famonomethoxine sodium propolis solution.
文摘A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the simultaneous estimation of Montelukast Sodium (MON) and Desloratadine (DES) in pharmaceutical dosage forms. The drugs were estimated using Hypersil BDS C18 (250 mm × 4.6 mm I.D., 5 μ particle size) column. The mobile phase composed of orthophosphoric acid and water in the ratio of 20:80 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 280 nm. The linearity range obtained was 10 - 30 μg/ml for MON and 5 - 15 μg/ml for DES with retention times of 2.929 min and 4.439 min for MON and DES respectively. The correlation coefficient values were found to be 0.999. Precision studies showed % RSD values less than 2% for both the drugs in all the selected concentrations. The percentage recoveries of MON and DES were in the range of 99.59% - 99.82% and 99.60% - 99.80% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.176 μg/ml, 0.587 μg/ml for MON and 0.087 μg/ml, 0.292 μg/ml for DES respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available tablet dosage forms.
