Analytical method development and validation of prasugrel hydrochloride in bulk and its pharmaceutical formulation using the GC-MS, HPLC method Epuru Manohar Reddy1,2,**, Venna Ravinder Reddy2, Narsimhulu Sravan2, Pilli Veera Venkata Nanda Kishore1,* 1Department of Chemistry, School of Applied Sciences and Humanities, VFSTR, Vadlamudi, Guntur, Andhra Pradesh, 522213, India 2Analytical Research and Development, Innovare Labs Private Limited, Hyderabad, Telangana, 500090, India *Corresponding Author E-mail: vfstrresearch1@gmail.com
**manoharreddyepuru1@gmail.com
Online Published on 31 August, 2024. Abstract 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. Top Keywords GC-MS, HPLC, Method development, Validation, Prasugrel HCl, 1-bromo-1-(2-fluorophenyl) propan-2-one. Top |