STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF DROTAVERINE HYDROCHLORIDE IN BULK AND ITS FORMULATION

Author(s): S. K. Panda*, B. S. Khuntia, R. R. Sarangi, S. K. Sahoo and Dhiraj Kumar

Abstract: A simple, rapid and accurate stability indicating RP-HPLC method was developed for the determination of Drotaverine Hydrochloride in pure and tablet form. The method was carried out using Phenomenex ODS C-18 column (250 x 4.6 mm, packed with 5 micron) using Acetonitrile and Water (50:50) with 0.05% glacial acetic acid as the mobile phase with detection at 357 nm and a flow rate of 0.5 ml/min. The retention time was found to be 4.260 min. The responses were linear in concentrations range of 10-120 µg/ml with correlation coefficient of 0.999. The percentage recovery was found to be between 98.01-101.69% and %RSD from recovery studies was found to be less than 1. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat and photolytic degradation. The degradation studies indicated the drug to be susceptible to acid and alkali hydrolysis. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision, ruggedness and robustness and can be successfully applied for determination determination of these drugs in commercial tablets.

PAGES: 536-545  |  59 VIEWS  51 DOWNLOADS