Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation

Abstract

Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.288 99.632% indicating excellent accuracy with percentage RSD Values less than 2. The method was precise, with a relative standard deviation of less than 2% for all tha validation parameters. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercials. Keywords: UV-Spectrophotometric, Enoxaparin sodium, Validation, ICH guidelines