Analytical Method Development and Validation of Clotrimazole and Mometasone Furoate in Its Bulk and Pharmaceutical Dosage Form BY RP-HPLC

A Novel, Simple, Sensitive, and Economic Revers-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of Clotrimazole and Mometasone Furoate in bulk and pharmaceutical dosage form. The Chromatographic condition was carried out by using Agilent C18 column (250 mm length x 4.6mm, 5μm Particle Size) with a mobile phase consisting of Methanol: (0.1%OPA) Water (75: 25 % v/v). The pH 3 was adjusted by using OPA. The detection was carried out at 230nm and retention time of Clotrimazole and Mometasone furoate was found to be 3.339 min and 7.848 min at a flow rate of 1.0 mL/min with the run time of 18 min. Linearity was observed from 20 to100μg/mL for Clotrimazole and 2-10μg/mL for Mometasone furoate with excellent R2 value of 0.999 and 0.999 with equation, y=22.39x+33.15 and y=49.02x+5.664 respectively. The % Relative standard deviation for approach precision is less than 2.0 %. The Detection Limit and Quantitation Limit of Clotrimazole and were found to be 0.100μg/mL and 0.304μg/mL respectively. The Detection Limit and Quantitation Limit of Mometasone furoate were found to be 0.029μg/mL and 0.088 μg/mL respectively. The developed chromatographic method was validated with respect to the ICH Q2 (R2) guidelines for Linearity, Precision, Range, Accuracy, Robustness, Detection Limit, and Quantitation Limit. The result which are obtained from the method validation were within the acceptable limit as per ICH guidelines. The developed RP-HPLC method takes much less time it can be used in the industry for routine quality control analysis of Clotrimazole and Mometasone furoate bulk drugs.