QUALITATIVE AND QUANTITATIVE ASSESSMENT OF RELATED SUBSTANCES IN THE CLOBETASOL PROPIONATE IN TOPICAL CREAM DOSAGE FORM BY RP-HPLC

Abstract

The identification and control of impurities in drug substance and drug product is considered as very critical factor by regulatory agency for safe and effective use of Drug product for its intended use. A specific and sensitive Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method is developed and validated for the estimation of 11 specified impurities in Topical Clobetasol Propionate Cream. The chromatographic parameters for develop method are C18 column, proportion of Water: Methanol: Acetonitrile: Trifluoro acetic acid as mobile phase at flow rate of 1.2 ml/min and UV detection at 241 nm. The method is validated for parameters as specified in ICH guideline. Developed method is validated for range 0.05–0.75 μg/mL for which Linearity, accuracy and precision was proven with acceptable limits. Method is sensitive as established Limit of Detection (LOD), and Limit of Quantitation (LOQ) are 0.02% and 0.06% respectively.