Author(s):
Manohar Reddy Epuru, Ravinder Reddy Venna, Sravan Narsimhulu, Veera Venkata Nanda Kishore Pilli
Email(s):
vfstrresearch1@gmail.com , manoharreddyepuru1@gmail.com
DOI:
10.52711/0974-4150.2024.00021 
Address:
Manohar Reddy Epuru1,2, Ravinder Reddy Venna2, Sravan Narsimhulu2, Veera Venkata Nanda Kishore Pilli1*
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
Published In:
Volume - 17,
Issue - 2,
Year - 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.
Cite this article:
Manohar Reddy Epuru, Ravinder Reddy Venna, Sravan Narsimhulu, Veera Venkata Nanda Kishore Pilli. Analytical method development and validation of prasugrel hydrochloride in bulk and its pharmaceutical formulation using the GC-MS, HPLC method. Asian Journal of Research in Chemistry. 2024; 17(2):103-0. doi: 10.52711/0974-4150.2024.00021
Cite(Electronic):
Manohar Reddy Epuru, Ravinder Reddy Venna, Sravan Narsimhulu, Veera Venkata Nanda Kishore Pilli. Analytical method development and validation of prasugrel hydrochloride in bulk and its pharmaceutical formulation using the GC-MS, HPLC method. Asian Journal of Research in Chemistry. 2024; 17(2):103-0. doi: 10.52711/0974-4150.2024.00021 Available on: https://ajrconline.org/AbstractView.aspx?PID=2024-17-2-9
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