A stability indicating RP-HPLC method for the simultaneous estimation of metronidazole, clindamycin and clotrimazole in bulk and their combined dosage form

Abstract

A simple, specific, and precise stability indicating reverse phase high performance liquid chromatography method was developed and validated as per the ICH guidelines for the simultaneous determination of Metronidazole, Clindamycin and Clotrimazole in bulk and combined dosage forms. The quantification was carried out by using Hypersil BDS C18 (4.6*250mm, 5mm) column at 30⁰c with Phosphate Buffer pH 4.5: Methanol: Acetonitrile in the ratio of 30:20:50 % V/V as mobile phase, pH 4.5 adjusted by using 0.1M ortho phosphoric acid. The flow rate is 1 mL/min and the estimation is carried out by using PDA detector at 210 nm. The retention time of Metronidazole, Clindamycin and Clotrimazole were 1.636, 2.289 and 4.928 minutes respectively. The linearity was observed from 25-150μg/mL with correlation coefficient 0.999 for Metronidazole, Clindamycin and Clotrimazole. The LOD and LOQ of Metronidazole, Clindamycin and Clotrimazole were found to be 1.77 & 5.35μg/mL, 2.55 & 7.77μg/mL and 1.28 & 5.25μg/mL respectively and the statistics data for the MNZ, CDM and CTM were concluded that the method was found to be simple, reliable, selective, reproducible and accurate. The method was successfully used for quality control analysis of Metronidazole, Clindamycin and Clotrimazole.