New Validated RP-HPLC Method For The Estimation of Ertapenem In Pharmaceutical Formulation

Abstract

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Ertapenem in Bulk and Pharmaceutical tablet Formulation. Isocratic elution at a flow rate of 1.5 ml/min was employed on symmetry Shimadzu LC-20 ATVP Kromasil C-18 Column at ambient temperature. The mobile phase consisted of 0.01M Potassium di-hydrogen phosphate : Water : Acetonitrile (25:50:25 v/v) . The UV detection wavelength was 295nm and 20µl sample was injected. The run time for Ertapenem is 15 min. The Percentage assay of Ertapenem in formulation was found to be 100.01%. The amount of drug present in the human sample was found to be 0.287 mg/ ml The limit of detection for Ertapenem was found to be 20µg/ml and the limit of quantification was found to be 50µg/ml.The method was validated as per the ICH guidelines. The method was successfully applied for routine quality control analysis of pharmaceutical formulation. The HPLC method can be successfully applied for the routine quality control analysis of Ertapenem formulations.