Development and Validation of RP-HPLC Method for Quantitative Estimation of Corticosteroid in Bulk Drug and Pharmaceutical Formulation
DOI:
https://doi.org/10.64149/J.Carcinog.23.1.785-792Keywords:
Validation, Corticosteroid, forced degradations, HPLC, stability indicating methods, ICH.Abstract
A simple, precise and stability-indicating HPLC method was developed and validated for the determination of Corticosteroid in bulk and pharmaceutical dosage forms for effective quality control. The drug was subjected to forced degradation under acidic, alkaline, neutral, oxidative, thermal and photolytic conditions, and was found to be stable under thermal and photolytic stress, while showing significant degradation under acidic, alkaline and oxidative conditions. Chromatographic separation was achieved on a Kromasil C18 column using an isocratic mobile phase of 20 mM potassium phosphate buffer (pH 6.2) and acetonitrile (50:50, v/v) with UV detection at 266 nm. The method showed linearity in the range of 20–100 µg ml⁻¹ with a retention time of 5.232 min, and LOD and LOQ values of 4.52 and 14.12 µg ml⁻¹, respectively. The method was validated according to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q2 (R1) guidelines and demonstrated acceptable analytical greenness with an AGREE score of 0.60.
