Development And Validation Of A New Hplc Method For The Estimation Of Azithromycin In Bulk And Tablet Dosage Form

A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for quantitative determination of azithromycin in drug substance. The separations were carried out on a Xterra C-18 column (150 x4.6 mm; 5 mu) with UV detection at 215 nm. The mobile phase consisting of acetonitrile and phosphate buffer (pH adjusted to 7.5) in a ratio of 50: 50 v/v. The injection volume was 50 mu l and flow rate was 1.0 mL/min. The linear dynamic response was found to be in the concentration range of 300 mu g-700 mu g/mL and coefficient of correlation was found to be 0.998. The % RSD value was below 2.0 for intraday and interday precision indicated that the method was highly precise. The percentage recovery value was higher than 100 %, indicating the accuracy of the method and absence of interference of the excipients present in the tablet formulation. The proposed method was simple, economic, accurate, precise and reproducible and hence can be applied for routine quality control analysis of azithromycin in bulk and dosage form.