Chromatographic estimation of cefetamet pivoxil in bulk and tablet dosage form: Development and validation approach

Cefetamet pivoxil is an oral third generation cephalosporin class of antibiotic which is mainly used in the treatment and management of both upper and lower community acquired respiratory tract infection. Many branded and generic formulations are available in tablet dosage forms in market, hence the quality control of Cefetamet pivoxil play an important role in pharmaceutical industry. In the present research work an attempt has been made to develop and validate cost effective, simple, precise, robust and rugged chromatographic method for estimation of Cefetamet pivoxil in bulk and tablets. Chromatographic method was developed using HPLC instrument. The separation was based on isocratic reverse phase chromatographic mode using C-18 column as stationary phase and mobile phase composed of acetonitrile: water (80:20 v/v) at ambient temperature using UV detection at 251 nm. Developed method was validated by analyzing parameters such as specificity, selectivity, linearity, range, precision, robustness, ruggedness, detection limit, quantification limit and drug recovery. All the method validation reportwas found to be within the acceptance as per ICH guidelines. Linearity was found between the range of 10 – 50 mg/ml. The results obtained from the validation data showed that method was specific, selective, linear, precise, accurate, robust and rugged and hence can be used for estimation of Cefetamet pivoxil in bulk and tablets dosage forms.