Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CEFOPERAZONE AND TAZOBACTAM IN THEIR COMBINED DOSAGE FORM

Narender Kumar*, Prasanna Kumar Pradhan, Pratik Rajput , Brijesh Joshi and Umesh Upadhyay

ABSTRACT

A simple, rapid and precise reversed phase HPLC (RP-HPLC) method has been developed for simultaneous determination of Cefoperazone (CEF) and Tazobactam (TAZ) in bulk and combined dosage form. Chromatographic separation was carried out on ODS C-18(250 × 4.6mm, 5- μm particle size) column using a mobile phase consisting of Phosphate Buffer (ph-4): Methanol (75:25) at a flow rate of 1.0 ml and with UV detection at 230 nm at column temperature (30º C) . The runtime under these chromatographic condition was 10 minutes. The method was linear over the range of 25-50 μg/ml for CEF and 3.125- 9.37 μg/ml for TAZ. The limit of detection (LOD) was 0.62 for CEF and 0.12 for TAZ respectively. The limit of quantitation (LOQ) was 1.87 for CEF and 0.38 for TAZ respectively. The purposed method was further applied to the determination of CEF and TAZ in marketed formulation with good percent recovery. The accuracy and precision of the method were validated on intraday and interday basis in accordance with ICH guidelines.

Keywords: Cefoperazone (CEF),Tazobactam (TAZ),ICH guidelines ,Validation.