Development and Validation of a Precise Liquid Chromatographic Method for the Analysis of Azithromycin

Abstract

Abstract A simple, reliable, precise and isocratic, rapid and accurateHigh Performance Liquid-Chromatographic method was developed and validated for the estimation of Azithromycin in pharmaceutical dosage. The HPLC analysis was performed on the C8 column (250 mm, 460 mm id, 5 um particle size) in isocratic mode. The mobile phase consist of a mixture of methanol 20% and 80% Buffer pH 7.5 (Buffer composition: potassium dihydrogen orthophosphate 2.5 gm in 500 ml filter distilled water and adjusted to pH 7.5 by sodium hydroxide 2N). This proved to give sharp peak of Azithromycin at a retention time of 8.5i2 min. HPLC analysis of Azithromycin was carried out at wavelength of 2l5nm with a flow rate of lml/min. The proposed method was developed and validated according to ICH guidelines and values of linearity, accuracy, precision and other statistical a.nalyses were found to be in complete accordance with the prescribed values.The method was found linear in the range 80-120% with the coeflicient of determination (R2) being 0.999. The intta- and inter day RSD (n=6) was 52.0%. The developed method was successfully applied for determination of Azithromycin and the results by HPLC may enabling the utility of this new method for routine analysis of azithromycin in pharmaceutical dosage forms. Key words: Azithromycin determination by, I-IPLC-Chromatography METHOD. < 186