Abstract

Simple and precise UV spectrophotometric methods by UV spectroscopy and area under curve [AUC] – in zero order derivative spectrum have been developed and validated for the estimation of drotaverine hydrochloride in pharmaceutical formulation. The standard and sample solutions of drotaverine hydrochloride were prepared in methanol. Drotaverine hydrochloride was estimated at 230 nm for the UV-spectrophotometric method (A), while in area under curve (AUC) method (B) the zero order spectrum of drotaverine hydrochloride was measured in between 225-235 nm. Beer’s law was obeyed in the concentration range of 1 to 24 µg / ml with coefficient of correlation value 0.002261 for zero order method. Similarly in AUC method, Beer’s law was obeyed in the concentration range of 5 to 50 µg / ml with coefficient of correlation value 0.6238. These methods were validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation were of 0.002261 % and 0.1403 % for the above two methods respectively. The proposed methods were successfully applied for the determination of drotaverine hydrochloride in pharmaceutical formulation. Results of the analysis were validated statistically and were found to be satisfactory. The proposed methods are simple, easy to apply, low-cost and require relatively inexpensive instruments.

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