Analytical method development and validation of hydrocortisone and clotrimazole in topical dosage form using RP-HPLC

Abstract

Abstract Background Different pharmaceutical topical agents are available in the market for the treatment of fungal infections. A simple, precise, and cost-effective RP-HPLC method was developed and validated for the determination of hydrocortisone and clotrimazole simultaneously in a topical cream dosage form. Chromatographic separation was done on USP L1 (250 × 4.6) mm column with a particle size of 5 μm. The mobile phase employed for this study consists of acetonitrile and buffer in the ratio of 75:25, respectively. The flow rate was kept at 1 mL per minute. The detection of the drug was carried out at 254 nm using a UV detector. The retention times of HYD and CL were 3.0 min and 7.3 min, respectively. Result The method is developed and validated for linearity, precision, specificity, accuracy, and robustness. Conclusion The stability of finished products gives us knowledge about the effect of different environmental factors like humidity, light, and temperature, and these factors give us information about the quality of finished products.

Keywords

• RP-HPLC
• Validation
• Stability study
• Stress testing
• Accuracy
• Precision