Simultaneous estimation and validation of Drotaverine Hydrochloride and Nimesulide in tablet dosage form using Reversed-Phase HPLC
By Raj K. Prasad, Rajesh Sharma
A simple, rapid, fast and precise reversed-phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of drotaverine hydrochloride and nimesulide in tablet dosage form. Best separation was achieved using a Luna C18 (5µm×25cm×4.6mm i.d) column with the flow rate of 1.0 ml min-1. The analytes were monitored at 239 nm. The mobile phase consisted of acetonitrile - triethylamine – water (65:0.3:34.7 v/v/v), adjusted to pH 4.5 with 5% o-phosphoric acid. Under this conditions the retention time were of 4.14 and 5.87 minute respectively for drotaverine hydrochloride and nimesulide, indicating that the compounds were well separated. Total run was completed within eight minute. The method was validated for accuracy, precision, linearity, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for quantitative analysis of commercial formulation Nobel spas tablets. Validation study revealed that the method is specific, rapid, accurate, precise, reliable and reproducible.
Keywords : Drotaverine Hydrochloride, Nimesulide, RP-HPLC.