Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE ESTIMATION OF CEFADROXIL IN BULK AND TABLET DOSAGE FORM

Kirankumar S. V.*, Jose Gnana Babu C. and Sowmya H. G.

Abstract

A new simple and precise reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the estimation of Cefadroxil in bulk and its pharmaceutical dosage form. The chromatographic separation was performed by using mobile phase consisting of KH2PO4: methanol in the ratio of 65:35% v/v and the pH 3.5 adjusted with 0.2% orthophosphoric acid. The column used was Hypersil C (150 × 4.6 mm, 5μ) with flow rate of 1 ml/min using PDA detection at 250 nm. Thermostat column compartment connected with Waters (alliance) Empower software. The described method was found to be linear over the range of 0.2-1.0μg/ml and correlation coefficient was found to be 0.9993 with a retention time of 3.157min. The assay of Cefadroxil was found to be 99.98 %. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise, reliable, accurate and economical which is useful for the routine determination of Cefadroxil in bulk and its pharmaceutical dosage form.

Keywords: Cefadroxil, method validation, ICH guidelines.[17]