Development and Validation of Liquid Chromatographic Method for the Analysis of Azithromycinf

Abstract

Abstract A simple, reliable, precise and isocratic, rapid and accurate High Performance Liquid-Chromatographic (HPLC) 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 μm particle size) in isocratic mode. The mobile phase consists 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 (2N)sodium hydroxide).This was found to give sharp peak of Azithromycin at a retention time of 8.5±2.min. HPLC analysis of Azithromycin was carried out at a wave length of 215 nm with a flow rate of 1.0 ml/min.The proposed method was developed and validated according to ICH guidelines and values of linearity, accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. The method was found linear in the range 80 – 120 percent with the coefficient of determination (R2) being 0.999. The intra-and inter-day RSD (n=6) was < 2.0%.The developed method was successfully applied for determination of azithromycin and the results by HPLC and thus enabling the utility of this new method for routine analysis of azithromycin in pharmaceutical dosage forms