Development and validation of analytical methods for some topical steroids anti acne drugs and antifungal drugs in bulk powder and their pharmaceutical dosage forms

Abstract

A stability indicating RP-HPLC method was developed with accuracy of 98.0 to 99.7%, 98.4 to 99.5% and 98.8 to 99.4% for MP, MTS and EBZ, respectively. Method was proved as linear in concentration range of 0.25 188 µg/mL, 0.50 75 µg/mL and 2.0 750 µg/mL for MP, MTS and EBZ, respectively. The method was proved to be robust by DOE study. The method was validated for method precision, specificity, linearity, accuracy, robustness and solution stability as per ICH guidelines. newline A novel stability indicating RP-HPLC method was developed for simultaneous estimation of CP, ADA, PHE and MP in topical gel formulations. A method was optimized with unique diluent system for extraction of CP and ADA from gel matrix. The method was validated for method precision, specificity, LOD and LOQ, linearity, robustness and solution stability as per ICH guideline. The accuracy of method is 97.2 to 102.5%, 97.6 to 102.5%, 97.9 to 101.4% and 100.5 to 103.0% for PHE, MP, CP and ADA respectively. newline A stability indicating RP-HPLC method was developed for the estimation of related substances of BPO and CP using common chromatographic conditions. Unique diluent system was established for BPO and CP to avoid interaction between both APIs. The method was validated as per ICH guideline and utilized for the related substances estimation in marketed gel formulations. newline A rapid stability indicating UPLC method was developed for assay and impurity profile of TER in bulk powder and topical cream formulations. The method was validated for method precision, specificity, LOD and LOQ, linearity, accuracy, robustness and solution stability as per ICH guideline. The method was optimized and proved to be robust by conducting DOE study with variable chromatographic conditions. The method was found to be linear for quantification of TER in concentration of 0.26 -80 µg/mL. The proposed method was capable to quantitate TER and its related impurities in the presence of blank and placebo peaks, enabling as stability indicating power of the method.