DEVELOPMENT OF ANALYTICAL SPECIFICATIONS AND VALIDATION OF DEFLAZACORT USING RP-HPLC

Background: Deflazacort is a synthetic glucocorticoid used for its anti-inflammatory and immunosuppressive effects. Reliable analytical methods are required for its accurate estimation in pharmaceutical formulations and for routine quality control. The present study aimed to develop and validate a simple, accurate, precise, robust, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of Deflazacort. Methods: The RP-HPLC method was developed using a reversed-phase C18 column (250 × 4.6 mm, 5 µm) with acetonitrile:water (80:20, v/v) as the mobile phase. The flow rate was maintained at 1.0 mL/min, injection volume was 20 µL, and detection was performed at 244 nm. Deflazacort standard and marketed tablet sample solutions were prepared and analyzed under the optimized chromatographic conditions. The method was validated for specificity, linearity, accuracy, precision, robustness, and solution stability. Forced degradation studies were performed under acidic, alkaline, oxidative, thermal, and photolytic stress conditions. Results: The developed method produced a distinct Deflazacort peak at approximately 4.18 min. The method showed good linearity over 50–150 µg/mL, with a correlation coefficient of 0.9998 and R² of 0.9996. The mean recovery was 99.59%, while precision and repeatability showed 0.08% RSD and intermediate precision showed 0.07% RSD. The method remained robust following deliberate changes in chromatographic conditions, and standard and sample solutions remained stable for 48 hours. Forced degradation showed the highest degradation under alkaline conditions (14.58%), followed by oxidative (10.34%), acidic (7.46%), photolytic (6.09%), and thermal (3.62%) conditions. The degradation peaks were adequately separated from the Deflazacort peak. Application of the method to the marketed tablet formulation gave a mean assay of 99.17% of the labelled claim with 0.42% RSD. Conclusion: The developed RP-HPLC method was found to be specific, accurate, precise, robust, and stability-indicating. The method can be suitably applied for the routine quantitative analysis and quality control of Deflazacort in pharmaceutical formulations.