Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFTOLOZANE AND TAZOBACTAM IN INJECTION

Sujatha J., Maneesh M., Nagamallika G.* and Chandrashekhar B.

Abstract

A simple, selective, linear, precise and accurate reverse-phase highperformance liquid chromatography technique was urbanized and validated for the concurrent determination of Ceftolozane and Tazobactam in powder for injection. The chromatographic separation was achieved on Altima C18 4.6×150mm, 5.0 μm column by means of a mobile phase consisting a mixture of Methanol: Water in a proportion of 65:35v/v at a flow rate of 1ml/min at room temperature and detection was carried out at 285nm. The clear chromatography peaks were identified with retention times of 2.09min for Ceftolozane and 6.07 min for Tazobactam. The proposed technique was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The linearity was observed in the concentration range of 10-40μg/ml for Ceftolozane and 5-25μg /ml for Tazobactam. A linear regression coefficient for both drugs was 0.999. The percentage recovery of Ceftolozane and Tazobactam was 100.9% and 99.6%. The %RSD for repeatability and intermediate precision was less than 2%. LOD was 0.8μg/ml and 0.9μg/ml and LOQ was 2.5μg/ml and 2.9μg/ml for Ceftolozane and Tazobactam respectively. The results of validation parameters were met ICH requirements. Hence, the projected method can be used for the estimation of Ceftolozane and Tazobactam in powder for injection during regular and quality-control analysis.

Keywords: Ceftolozane, Tazobactam, Simultaneous estimation, RP-HPLC, Injection.