Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CLOXACILLIN AND CEFIXIME SIMULTANIOUS IN TABLET DOSAGE FORM BY RP-HPLC

Dr. M. Prasadarao and S. Lakshmi Sumanoja*

Abstract

A simple reverse phase high perfomence liquid chromatographic method has been developed and subsequently validatedfor simultaneous determination of cefixime and cloxacillin in combined dosage form. The separation was carried out using a mobile phase consisting of methanol and mono basic potassium phosphate buffer in the ratio of 60:40 v/v. The column used was Inertsil –ODS C18 (250 × 4.6 mm, 5μ) with flow rate of1.0ml/min using PDA detection at 272nm. The described method was linear over a concentration range of 20ppm to 80ppm for the assay of cefixime and cloxacillin respectively. The retention times of cefixime and cloxacillin were found to be 2.955min and 3.532min respectively. Results of analysis were validated statistically and by recovery studies. The limit of quantification (LOQ) for cefixime and cloxacillin were found to be 0.77mg/ml and 1.05mg/ml respectively. Then the limit of detection (LOD) for cefixime and cloxacillin were found to be 0.25 mg/ml and 20.34 mg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate which is useful for the routine determination of cefixime and scloxacillin bulk drug and in its pharmaceutical dosage form.

Keywords: cefixime, cloxacillin, methanol.