Novel HPLC method for quantitative determination of cefazolin sodium in pharmaceutical formulations

Abstract

This paper reports a validated high-performance liquid chromatography method which is rapid, highly specific, and accurate for determination of cefazolin sodium in injectable pharmaceutical formulations. Separation was carried out using a Hibar ® µBondapak ® C 18 column with a mobile phase consisting of an acetonitrile to monobasic sodium phosphate buffer ratio of 17:83 and a flow rate of 1.0 mL per minute, and monitoring at a wavelength of 254 nm. The calibration curve was linear, with a correlation coefficient .0.9995 in the range of 5-100 µg/mL. Drug recovery was 98.35%-100.86%, with a limit of detection of 12.92 ng/mL and a limit of quantification of 43.09 ng/mL. The drug was subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation), where maximum degradation was observed. Forced degradation studies confirmed stability indicating power of this method, which was validated in accordance with International Conference on Harmonization guidelines and used successfully to quantify the amounts of cefazolin sodium in bulk injectable formulations and in physiological fluid.