Original Articles
A. J. Vyas, J. K. Patel, J. R.
Abstract
A simple, precise, and accurate isocratic RP-HPLC method was developed and validated for determination of Drotaverine hydrochloride (DROT) and Nimesulide (NIM) in bulk drug and tablet dosage form. Isocratic RP-HPLC separation was achieved on a Varian Microsorb mv C18 column (250 4.6 mm id, 5 mm particle size) using the mobile phase Water: Acetonitrile: Methanol: TEA (53:38:9:0.2) and pH adjusted to 3.0 pH with orthophosphoric acid at a flow rate of 1.5 ml/min. The retention time of drotaverine hydrochloride and nimesulide were 3.005 and 4.956 min., respectively. The detection wavelength was 306 nm and samples of 20 μl were manually injected. The method was validated for linearity, precision, accuracy, robustness, and specificity. The method was linearity in the concentration range of 4–80 μg/ml for drotaverine hydrochloride and 5-100 μg/ml for nimesulide. The limit of detection and limit of quantification for drotaverine hydrochloride were 0.1907 and 0.5781 μg/ml, respectively, and for nimesulide 0.2614 and 0.7921 μg/ml, respectively. The accuracy (recovery) was found to be in the range of 98.98–100.99 % for drotaverine hydrochloride and 98.89–101.07% for nimesulide.