Abstract

SIMULTANEOUS ESTIMATION OF AZITHROMYCIN AND CEFIXIME IN BULK AND PHARMACEUTICAL FORMULATION BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)

Usharani Gundala*, Chandrashekar Bonagiri , Devanna Nayakanti

Abstract

Azithromycin and Cefixime are both antibiotics drugs. As there is no UV or HPLC method for the simultaneous estimation of Azithromycin and Cefixime, a need was felt to develop the method for the analysis of both drugs simultaneously. This work concerns with the development and validation of a simple, specific and cost effective RP-HPLC method for simultaneous estimation of Azithromycin and Cefixime in bulk. In addition the developed method was applied to the suitable combined tablet dosage form ie., Zifi-AZ. Chromatography was carried on Kromasil C18 column with mobile phase comprising of Ortho Phosphoric Acid buffer and Methanol in the ratio of 70:30 v/v. The flow rate was adjusted to 1ml/min with PDA detection at 292 nm. The retention times of Azithromycin and cefixime were found to be 2.8 min, 3.9 min respectively and other replicate standard system suitability parameters are within the limit and uniform. The different analytical parameters such as accuracy, precision, linearity, robustness, limit of detection (LOD), limit of quantification (LOQ) were determined according to the International Conference on Harmonization (ICH) Q2B guidelines. The detector response was linear in the range of 0.5- 1.5 mg/ml., 0.4-1.2 mg/ml for Azithromycin and cefixime respectively. The proposed method was successfully applied for the reliable quantification of active pharmaceuticals present in the commercial formulations.

Keywords: Azithromycin, Cefixime, HPLC, Methanol, Ortho Phospharic Acid.