Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

Abstract

Method development and validation of HPLC method for determination of azithromycin

Author(s): Sangita N Waghule, Nitin P. Jain, Chetan J Patani and Aparana C. Patani

A simple, selective, precise and accurate High Performance Liquid Chromatographic Method for the analysis of Azithromycin in its formulations was developed and validated in the present study. The mobile phase consist a mixture of 0.0335M Phosphate Buffer (pH 7.5) and Methanol in the proportion 20:80. This was found to give sharp peak of Azithromycin at a retention time of 8.35min. HPLC analysis of Azithromycin was carried out at a wavelength of 210nm with a flow rate of 1.2ml/min. The linear regression analysis data for the calibration curve showed a good linear relationship with a regression coefficient 0.997. The linear regression equation was y = 18930x - 10493. The developed method was employed with a high degree of precision and accuracy for the analysis of Azithromycin. The method was validated for accuracy, precision, robustness, ruggedness, specificity. The precision, accuracy, sensitivity, short retention time and composition of the mobile phase indicated that this method is better for the quantification of Azithromycin.


PDF