A stability indicating RP-HPLC method development and validation for simultaneous quantification for assay of rifampicin in pharmaceutical solid dosage form

Abstract

A cost effective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) for simultaneous quantification for assay of Rifampicin in pharmaceutical solid dosage form (tablets) was developed and validated. Chromatographic procedure was conducted using stationary phase packing c18 column (Luna), having 5 µm particle size with inner diameter (250 x 4.6) mm, mobile phase consists of 60% acetate buffer (pH 4.5) and 40% acetonitrile (HPLC grade of sharlau manufacturer). The detection wavelength was uv 254 nm with flow rate of 1.0 ml/min and injection volume was 10 µL with run time 10 min. Based on proposed method validation was conducted following system precision, specificity or selectivity, method precision, accuracy, linearity, robustness, solution stability, limit of quantitation (LOQ), limit of detection. It was observed the system (Waters, HPLC) was precise enough to quantify Rifampicin, no interference of blank, placebo or other known impurity at the elution zone of Rifampicin; % RSD for six sample solutions of Rifampicin was 0.9% (% average assay: 98.7%); accuracy observed 101.1% for 80% recovery, 100.4% for 100% recovery and 100.5% for 120% recovery; co-relation coefficient of linearity (r =1.000); limit of quantification (LOQ) found 0.18 ppm.