Method Development and Validation of Rifampicin by Using RP-HPLC Method in Pharmaceutical Formulations

Abstract

A rapid and sensitive RP-HPLC method with UV detection (219nm) for routine analysis of Rifampicin in a pharmaceutical formulation was developed. Chromatography was performed with a mobile phase containing a methanol of assay (99.8%) with flow rate of 0.9ml/min. Quantitation was accomplished with an internal standard method. The procedure was validated for linearity (correlation coefficient = 0.9957), accuracy and limit of detection (LOD) intraday precision. To test validation of the Rifampicin three factors were considered as linearity, precision, LOD where mobile phase, flowrate and pressure are respectively selected as methanol, 0.9ml/min, 1200 pascals. To ensure precise intraday measurements, the variables taken into account were the analyst and the equipment. The RSD value (0.20%) indicated a good precision of the analytical method. The proposed method was simple; highly sensitive, precise, accurate and retention time less than 3 min indicating that the method is useful for routine quality control.