Development of in-vitro release testing method for permethrin cream formulation using Franz Vertical Diffusion Cell apparatus by HPLC

Abstract

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.