Development and validation of a stability – indicating RP –HPLC method for simultaneous estimation of and Sertaconazole Nitrate, Mometasone Fumarate and Preservatives in Tropical cream Formulation including Forced Degradation studies as per ICH guidelines

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Propyl Paraben, Mometasone and Sertaconazole Tropical dosage form. Chromatogram was run through   Sunfire C18 (250 x 4.6 mm, 5m). Mobile phase containing 0.01N Kh2po4 and Acetonitrile in the ratio of 65:35 A was pumped through column at a flow rate of 1ml/min.. Temperature was maintained at 30°C. Optimized wavelength for Propyl Paraben, Mometasone and Sertaconazole was 260nm. Retention time of Propyl Paraben, Mometasone and Sertaconazole were found to be 2.222min, 3.308min and 3.991min %RSD of system precision for Propyl Paraben, Mometasone and Sertaconazole were and found to be 0.3, 0.9 and 0.2 respectively. %RSD of method precision for Propyl Paraben, Mometasone and Sertaconazole We’re and found to be 0.3, 0.4 and 0.2 respectively. % recovery was obtained as 99.54%, 99.68% and 99.79% for Propyl Paraben, Mometasone and Sertaconazole Respectively. LOD, LOQ values are obtained from regression equations of Propyl Paraben, Mometasone and Sertaconazole were 0.03ppm, 0.05ppm, 0.38ppm, 0.08ppm 0.15ppm, and 1.16ppm respectively. Regression equation of Propyl Paraben was y = 23662x + 242.79, Mometasonee was y = 24014x + 212 and of Sertaconazole was y = 9851.3x + 1592.9