STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR ESTIMATION OF METRONIDAZOLE AND RIFAXIMIN IN TABLET DOSAGE FORM

A new, sensitive, and rapid stability indicating RP-HPLC method development for the estimation of metronidazole and Rifaximin in tablet dosage form. The Method was validated according to ICH guidelines concerning system suitability, linearity, accuracy, precision, specificity, LOD, LOQ and robustness. The developed method was found to be within the acceptable limits. For this, a gradient condition of the Mobile phase comprising Ammonium acetate buffer and acetonitrile in a ratio of 40:60 v/v at a flow rate of 0.7mL/min over the YMC ODS column at ambient temperature. The detection was performed at an isosbestic wavelength of 282 nm with a runtime of 6 mins. The retention time of the Metronidazole was 3.6 minutes and Rifaximin was 4.3 minutes. All the results of validation parameters were within acceptable criteria according to ICH guidelines. Metronidazole and rifaximin were subjected to acid, base, oxidative, thermal, and photolytic degradation. The main compounds' degradation products were well resolved, proving the stability-indicating method. As developed method was cost effective and less time-consuming as the developed method was used for routine analysis.