Development and Validation of RP-HPLC Method for Estimation of Drotaverine Hydrochloride and Nimesulide in Pharmaceutical Dosage Form

The present work describes a reverse phase high performance liquid chromatographic method for the simultaneous estimation of drotaverine hydrochloride and nimesulide in combined dosage forms. Chromatography was performed on Phenomenex Luna C18 (250 × 4.6 mm i.d. and particle size 5 μm) column in isocratic mode with mobile phase containing acetonitrile: 0.3% triethylamine aqueous solution (adjusted to pH 3.0 using 1 % ortho phosphoric acid) in the ratio of 75:25v/v. The flow rate was 1.0 mL/min and effluents were monitored at 246 nm. The selected chromatographic conditions were found to be useful in separating drotaverine hydrochloride (run time 2.435 min) and nimesulide (run time 4.019 min). Linearity for drotaverine hydrochloride and nimesulide was found to be in the range of 0.5-100 and 1.0-200 μg/mL, respectively with linearity coefficient of 0.9998 and 0.9993. Percent recovery of the drugs was found to lie between 99.87- 100.13. The proposed method was validated by different parameters. It was found to be accurate, precise, reproducible and specific and hence can be used for simultaneous analysis of these drugs in combined dosage forms.