Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CEFUROXIME AND LINEZOLID IN BULK AND PHARMACEUTICAL DOSAGE FORM

Y. Ramadevi, Sareesh K.*, Anasuri Santhosh and Sunil Kumar Chaitanya Padavala

ABSTRACT

RP-HPLC Method Development and Validation for Simultaneous Estimation of Cefuroxime and Linezolid in Bulk and Pharmaceutical Dosage form. A High performance liquidchromatograph WATERS, software: Empower 2, 2695 separation module, 996 PDA detector, using Phenomenex Luna C18 (4.6mm x 150mm, 5μm, Make: Waters) or equivalent column, with mobile phase composition of Acetonitrile: Phosphate Buffer (pH-6.8) [70:30 % (v/v)] was used. The flow rate of 1ml/min and effluent was detected at 230 nm. The retention time of Cefuroxime and Linezolid was found to be 2.813 min and 3.886 minutes respectively.Linearity was observed over concentration range of 25-125 μg ml-1 for Cefuroxime and 30-150 μg ml-1 for Linezolid respectively. The accuracy of the proposed method was determined by recovery studies and the Cefuroxime was found to be 99.8 % and Linezolid was found to be 99.4 % respectively. The proposed method isapplicable to stability studies and routine analysis of Cefuroxime and Linezolid in bulk and pharmaceutical formulations. The proposed method was validated for various ICHparameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.

Keywords: Cefuroxime, Linezolid, RP-HPLC, Robustness and ICH Guidelines.