ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HYDRALAZINE, ISOSORBIDE DINITRATE IN BULK AND TABLET FORMULATION BY RP-HPLCAbstract
A simple, sensitive, linear, precise and accurate RP-HPLC method for simultaneous estimation of Hydralazine, Isosorbide dinitrate in bulk and tablet formulation was developed and validated. The chromatographic separation of the three drugs was achieved on Zodiac C18 (250 mm ´ 4.6 mm) 5µ column in an isocratic mode. The mobile phase consisting of 0.01M 0.01 M Ammonium acetate : Acetonitrile : Methanol in the ratio of 50:30:20 v/v and pH adjusted to 3 using ortho phosphoric acid was delivered at a flow rate of 1ml/ min and effluents were monitored at 270 nm. The retention time of Hydralazine, Isosorbide Dinitrate was found to be 2.337 and 3.413 min, respectively. Calibration curves were linear with a correlation coefficient of 0.994 for HYD , and 0.997 for ISD over the concentration range of 45-105µg/ml for HYD, and 24-56 µg/ml for ISD and precise with (%RSD<2). The method was validated as per the ICH guidelines and can be employed for routine quality control analysis.
K. Neelima* and Y. Rajendra Prasad
Department of Chemistry, Sarojini Naidu Vanitha Pharmacy Mahavidyalaya, Exhibiton grounds, Nampally, Hyderabad-500001, Andhra Pradesh, India
28 October, 2013
22 January, 2014
24 March, 2014