Abstract

STABILITY INDICATING ASSAY PROCEDURE FOR METHOD DEVELOPMENT AND VALIDATION OF CEFDINIR IN ITS TABLET DOASGE FORM BY USING RP-HPLC

Seema Firdouse*, Parwez Alam, Abdul Mutalib, Farhin Begum, Asra Sultana, Nishath Kulsum

Abstract

A rapid and precise, linear, specific and suitable Reverse Phase High Performance Liquid Chromatographic method has been developed for the estimation of Cefdinir in its tablet dosage form. Chromatography was carried out on a Develosil C18 (4.6 × 150mm, 5 μm) column using a mixture of ACN and phosphate buffer (pH 3, adjusted with ortho phosphoric acid) in the ratio of 40:60 as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 254 nm. The retention time of Cefdinir was 6.31 min respectively. The method produced linear responses in the concentration range of 0-25 μg/ml. The method of precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and other pharmaceutical formulations.

Keywords: Cefdinir, RP-HPLC, Stability indicating Studies, Validation, Tablet dosage form.