NEW HPLC TECHNIQUE ADVANCEMENT AND APPROVAL OF CEIPIME – A FOURTH ERA ANTIBIOTIC
NDVR Saradhi* and Dr. M. Venkata Reddy
ABSTRACT
A simple and sensitive method was developed for estimation of Cefepime in its bulk and Pharmaceutical formulations and the method is validated according to ICH guidelines for routine practice in the Pharmaceutical industry and academic research and other fields associated with it. The method development was done with RP- HPLC with an equivalent pressure is maintained around 30 MPa, A mobile phase PH buffer 3.5 and acetonitrile in 50:50 (v/v) ratio. The column X terra C18 (4.6*150, 5μ) with a flow rate 0.8 ml/min a suitable retention peak was obtained on 4.266 min. this method was validated according to ICH guidelines. The system suitability, Linearity, precision, LOD, LOQ, and other stability studies were conducted and all are satisfied the guidelines and the method was suitable or regular practice in Pharmaceutical Analysis of Cefepime.
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