A new analytical method is developed for a generic drug product equivalent to the Reference Listed drug of Permethrin Cream formulations for an in-vitro release study using Franz Vertical Diffusion Cell apparatus in association with the analytical quantitation by High-Performance Liquid Chromatography. The importance of the in-vitro release study is to evaluate the formulation Q1/Q2 Sameness, where the test and reference products are proved to be qualitatively and quantitatively the same. The methodology has been evaluated with respect to Specificity, Linearity, the limit of quantitation (LOQ), limit of detection (LOD), inter-day Precision, intermediate Precision, Accuracy, and solution stability. The separation is achieved by using column Inertsil ODS-3V, 4.6 mm x 150 mm, a 5.0 µm column used, and column and sample temperature maintained at 35°C and 10°C, respectively. The in-vitro drug product is developed as per Product-Specific Guidance on Acyclovir Cream, 2016 and USP general chapter <1724> semisolid drug products-performance tests and analytical method validations evaluated as per International Conference on Harmonization (Q2) methodology.

为仿制药产品开发了一种新的分析方法，该方法相当于氯菊酯乳膏制剂的参考上市药物，用于使用 Franz 垂直扩散池装置进行体外释放研究，并结合高效液相色谱法进行分析定量。体外释放研究的重要性在于评估制剂 Q1/Q2 的相同性，其中证明测试产品和参比产品在定性和定量上相同。该方法已在特异性、线性、定量限 (LOQ)、检测限 (LOD)、日间精密度、中间精密度、准确度和溶液稳定性方面进行了评估。使用 Inertsil ODS-3V 色谱柱实现分离，4.6 mm x 150 mm，使用 5.0 µm 色谱柱，色谱柱和样品温度分别保持在 35°C 和 10°C。该体外药物产品是根据 2016 年阿昔洛韦乳膏产品特定指南和 USP 通则 <1724> 半固体药物产品开发的 - 性能测试和分析方法验证根据国际协调会议 (Q2) 方法进行评估。