Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CEFIXIME AND AZITHROMYCIN BY USING RP-HPLC

E. Sireesha*, L. Ramachandra Reddy and D. Dhachinamoorthi

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Cefixime and Azithromycin by using RP-HPLC. The chromatographic separation was achieved with 20mM Phosphate buffer (pH-5): Methanol: Acetonitrile (40:30:30, v/v/v), using the Equisil C18 column (250 X 4.6 mm, 5μ) at 260nm. The total analysis time was 10 min and flow rate was set to 1.0 mL/min. The standard curve shows correlation coefficient (r2) ≥0.999 with a range of 1-5 for cefexime and for Azithromycin 5-25μg/mL. The validated method was applied for the analysis of drugs in bulk and formulation (ZIMNIC-AZ Tablets). Hence, the developed chromatographic methods free from matrix interferences and useful in the analysis of drugs in pharmaceutical formulation. Precision of the developed methods was studied under intra and inter day precision. The %RSD values for precision was found to be within the acceptable limit, which revealed that the developed method was precise. The developed method was found to be robust. The %RSD values for percentage recovery was found to be within the acceptable criteria.

Keywords: Cefexime and for Azithromycin.