Analytical method development and validation for the simultaneous estimation of ceftolozane and tazobactam in pure and pharmaceutical dosage form by RP-HPLC

Abstract

The purpose of the present study was to develop a simple, accurate and precise method for the simultaneous estimation of Ceftolozane and Tazobactum in bulk and pharmaceutical dosage form by RP-HPLC. Chromatograms were run isocratic way through the synchronis C18 column (250 mm x 4.6 mm, 5μm) using the mobile phase consists of methanol and 1% sodium perchlorate in the ratio of (80:20) and pumped through the column with pressure 10.5±5MPa at a flow rate of 1ml/min. The temperature was maintained at 30°C. The optimised wavelength for Ceftolozane and Tazobactum was 254 nm. Retention times of Ceftolozane and Tazobactum were found to be 4.65 min and 8.86 min respectively. % RSD of the Ceftolozane and Tazobactum were found to be 0.523 and 0.599 respectively. The % Recovery of Ceftolozane and Tazobactum at each level was found to be not less than 98.11 %, 98.03 and not more than 99.84%, 100.10% respectively. The percentage purity of Ceftolozane and Tazobactum in combined dosage form were found to be 98.13% and 98.67% respectively. The coefficient of variance for both the drug was more than 0.999. The method was validated in terms of linearity, precision, accuracy, limits of detection, limits of quantification, and robustness according to International Conference on Harmonization (ICH) guidelines. The proposed method can be used for routine quality control analysis of Ceftolozane and Tazobactum in bulk and combined dosage forms.