STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF VANCOMYCIN HYDROCHLORIDE IN THE PHARMACEUTICAL DOSAGE FORMS

Abstract

A simple, rapid and selective RP-HPLC method was developed for the determination of vancomycin hydrochloride. The separation was achieved using a Capital C8-Optimal column (250 x 4.6 mm i.d., 5 μm particle size) with a mobile phase composed of buffer citrate (pH 4), acetonitrile and methanol in the ratio of 85 : 10: 5 (by volume), respectively. The mobile phase was pumped using an isocratic HPLC system at a flow rate of I mL/min and quantification of analyte was based on measuring its peak areas at 280 nm. Cephalexin monohydrate was used as internal standard (IS). The retention times for vancomycin hydrochloride and cephalexin were about 4.30 and 7.50, respectively. The reliability of the proposed HPLC procedure was validated with respect to linearity, ranges, precision, accuracy, specificity and detection limit. Calibration curve was linear in the ranges of 1-100 μg/mL with correlation coefficient of 0.9999. The proposed method proved to be selective and stability-indicating by the resolution of the analytes from the forced degradation (hydrolysis, oxidation, thermolysis and photolysis) products. The validated HPLC method was successfully applied to the analysis of vancomycin hydrochloride in pharmaceutical dosage forms. The degradation products resulted from the storage of the drug under stress degradation conditions described by the International Conference on Harmonisation (ICH).