DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF SERTACONAZOLE NITRATE AND MOMETASONE FUROATE IN TOPICAL FORMULATIONS

High-performance liquid chromatography (HPLC) method was successfully developed and validated for simultaneous estimation of Sertaconazole nitrate and Mometasone furoate in their combined dosage form. Chromatographic separation was achieved on a C18 (250 mm × 4.6 mm, 5 µm particle size), using Acetonitrile: 0.01M Sodium Dihydrogen Phosphate (70:30 v/v) (pH 4.69) as mobile phase at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 240 nm. The Sertaconazole nitrate and Mometasone furoate show linearity in the range of 100–500 µg/ml and 5–25 µg/ml respectively. The retention times of Sertaconazole nitrate and Mometasone furoate were found to be 9.929 min and 4.862 min respectively. The developed method was evaluated for precision, accuracy and robustness parameters also. The intraday and inter day precision data found to be less than 2 % RSD showing the method is precise. The accuracy study was performed using standard addition technique and found between 98–102 %. The Limit of Detection was found to be 0.172 and 0.046 for Sertaconazole nitrate and Mometasone furoate respectively. The limit of Quantitation was found to be 0.522 and 0.139 for Sertaconazole nitrate and Mometasone furoate respectively. The % RSD for robustness study was also found below 2%, indicates that the method is robust.