Analytical method development and validation of rifaximin and ornidazole in bulk and combined tablet dosage form as per ICH guidelines
K. Subhamalar, M. Vijey Aanandhi, Afroz Patan
Abstract
A precise and accurate HPLC method was developed for the detection of ornidazole and rifaximin in bulk and combination dosage form. Chromatography was done using acetonitrile and ammonium acetate buffer as the mobile phase, at a 65:35 ratio, on a 250 x 4.6 mm, 5 m hypersil C18 column. Based on the features superimposed on it, a detection wavelength of 280 nm was selected for the study. According to ICH criteria, the procedure was verified for rifaximin. Linearity was determined to be 100 to 300 g/ml for ornidazole 125 to 375 g/ml for rifaximin. Ornidazole and rifaximin both had correlation coefficients of 0.9999. The formulation analysis findings and the label claim were in good accord the accuracy of the approach was demonstrated by the percentage RSD, which was determined to be 0.15 per cent for ornidazole and 0.23 per cent for rifaximin, respectively, recovery studies validated the method precision. Ornidazole's percentage recovery was found to be between 100.54 per cent and 100.33 per cent and rifaximin percentage recovery was found to be between 99.90 per cent and 100.34 per cent, demonstrating the method accuracy. The findings of the validation parameters demonstrate the method adequacy for the simultaneous estimate of the chosen medicines. The suggested RP-HPLC processes are accurate, precise, robust, repeatable, and suitable for routine quality control analysis of rifaximin and ornidazole in bulk and in its combination medicinal dosage form.