DEVELOPMENT AND VALIDATION OF A NEW HPLC METHOD FOR THE ESTIMATION OF AZITHROMYCIN IN BULK AND TABLET DOSAGE FORMAbstract
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 C18 column (150 ×4.6 mm; 5µ) 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 µl and flow rate was 1.0 mL/min. The linear dynamic response was found to be in the concentration range of 300µg-700 µg/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.
Irin Dewan*, Tasnuva Amin , Md. Faisal Hossain , Moynul Hasan , Sayeeda Fahmee Chowdhury , Mahjabeen Gazi and S.M. Ashraful Islam
Assistant Professor, Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, Bangladesh
06 April, 2012
02 December, 2012
17 December, 2012
01 January, 2013