METHOD DEVELOPMENT AND VALIDATION FOR MEROPENEMAND VABORBACTAM BY RP-HPLC METHOD

A simple, Accurate, precise method was developed for the simultaneous estimation of the Meropenem and Vaborbactam in Tablet dosage form. Chromatogram was run through Inertsil ODS C185mm (4.6 x 250mm). Mobile phase containing Phosphate buffer and Acetonitrile in the ratio of 30:70 was pumped through column at a flow rate of 1ml/min. Buffer used at pH 4.6. Temperature was maintained at Ambient. Optimized wavelength for Vaborbactam and Vaborbactam was 260nm. Retention time of Meropenem and Vaborbactam were found to be 2.395min and 3.906min. The % purity of Meropenem and Vaborbactam was found to be 100.6% and 101.3% respectively. The system suitability parameters for Meropenem and Vaborbactam such as theoretical plates and tailing factor were found to be 1.3, 1012.4and 1.2, 1848.2 the resolution was found to be 9.0.The linearity study for Meropenem and Vaborbactam was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.1% and 100.4%, %RSD for repeatability was0.31 and 0.38, % RSD for intermediate precision was 0.12 and 0.15 respectively. The precision study was precise, robust and repeatable. LOD value was 2.94 and 3.03, and LOQ value was 9.87 and 10.1 respectively.

Keywords: Meropenem, Vaborbactam, RP-HPLC