Development and validation of a reversed-phase HPLC method for simultaneous estimation of azithromycin in tablet dosage form

Abstract

An isocratic, precise and accurate reversed-phase liquid chromatographic method was developed for the quantitative determination of Azithromycin in tablet dosage form. The separation was carried out using a mobile phase consisting of buffer Potassium dihydrogen Phosphate: Acetonitrile (HPLC grade) (pH 7.5 adjusted with ortho phosphoric acid). The column used was Hypersil- keystone C18 (250 X 4.60 mm), 5?m column with flow rate of 1.2 ml/min using U.V. Visible detector. The detection was monitored at 215nm and the run time was 25min. The volume of injection loop was 10?l prior to injection of the drug solution the column was equilibrated for at least 15 min. The retention times of Azithromycin were found to be 9.761. Results of analysis were validated statistically and by recovery studies. Forced degradation method is used for detection of degraded impurities in body fluids shows better results than reported. The results of the study conclude that the proposed RP-HPLC method is a simple, specific, definite, precise, and less time consuming method which is useful for the routine determination of Azithromycin in its pharmaceutical dosage form.