Impurity profiling of drotaverine API and It's formulation by RP-HPLC

Abstract

A related impurity method was developed and validated for determination and quantification of impurities of drotaverine hydrochloride in bulk drug and pharmaceutical formulations. The separation was accomplished on a phenomenex Luna C-18 (150 mm × 4.6 mm; particle size 5 μm) column under isocratic mode. The mobile phase was 0.0125 M potassium dihydrogen orthophosphate (pH 4.0): acetonitrile (57:43v/v), flow rate was 1.0 ml min-1 and a PDA detector set at 240 nm was used for detection.. The proposed method was validated in terms of accuracy, precision, reproducibility according to ICH guidelines and successfully applied to the analysis of commercial formulations. Three major impurities were found among all formulations. Quantification of IMP C of drotaverine hydrochloride was performed using Std. IMP C impurity sample and other two impurities were reported in percentage with respect to drotaverine. Forced degradation of drotaverine hydrochloride was also carried out under thermal, photo, acidic, alkaline and peroxide conditions and it was found that impurities generated due to degradation of drotaverine. Thus, the developed method can be used for impurity profiling as well as quality control of drotaverine hydrochloride in bulk drug and pharmaceutical formulations.