Analytical method development and validation of prasugrel hydrochloride in bulk and its pharmaceutical formulation using the GC-MS, HPLC method

The present work reports rapid, sensitive and specific methods for determination of Prasugrel and its impurities by gas chromatography with mass spectrometry and high-performance liquid chromatography. The proposed method presented excellent intraday precision (% RSD < 1), and accuracy 99.23 to 100.40% and 99.48 to 100.81% for Prasugrel and 2-bromo-1-cyclopropyl-2-(2-fluorophenyl) ethanone. Further the linearity of Prasugrel correlation coefficient is >0.9994 and for bromo impurity correlation coefficient is > 0.9993. The estimated limits of detection (LOD) and quantification (LOQ) for Prasugrel, 1-bromo-1-(2-fluorophenyl) propan-2-one ranged from 0.990 to 2.586 μg/mL, and 2.999 to 7.837 μg/mL respectively. The results demonstrated that the method should be regarded as a reliable alternative to the simultaneous determination of Prasugrel and its impurities. The EI mass spectrum of Prasugrel, fluoro, bromo, methyl bromo and dibromo impurities were characterized by [M + H]⁺ at 409, 189, 257, 231 and 311. The methods were validated according to ICH guideline.