Jinesh Bahubali Nagavi1* and Bannimath Gurupadayya2
1Sarada Vilas College of Pharmacy, K. M. Puram, Mysuru, Karnataka, India
2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS University, Mysuru, Karnataka, India
*Corresponding Author: Jinesh Bahubali Nagavi, Assistant Professor, Pharmaceutical Analysis, Sarada Vilas College of Pharmacy, K.M. Puram, Mysuru, Karnataka, India.
Received: July 15, 2018; Published: August 07, 2018
Citation: Jinesh Bahubali Nagavi and Bannimath Gurupadayya. “MS/MS and HPLC Characterization of Forced Degradation Products of Clopidogrel and Pantoprazole Sodium”. Acta Scientific Pharmaceutical Sciences 2.9 (2018).
Objective: To develop a simple, precise and accurate reverse phase high performance liquid chromatographic method for the evaluation of Clopidogrel (CLP) and Pantoprazole Sodium (PAN) succeeding degradation studies as per the ICH guidelines.
Methodology: The degradants and active drugs were separated by thin layer chromatography and exposed to structural elucidation by mass spectrometry with electron spray ionization (ESI) technique. The degradation products were detected in alkali and acid hydrolysis for Clopidogrel; whereas Pantoprazole Sodium exhibited degradation on exposure to light.
Results and Discussion:The base peak of CLP with m/z of 501.6 was formed in positive ESI mode. The daughter ion of CLP was observed at m/z of 418.3. Two degradants with m/z of 524.1 and m/z of 507.8 were formed by acid hydrolysis to give a carboxylic acid derivative and another by dehydrogenation respectively. Degradation product with m/z of 553.3 was di-sodium adduct of CLP and was formed in alkaline hydrolytic condition. The base peak of photo degradant of PAN with m/z of 419.1 was formed in positive ESI mode showed same m/z value of the base peak of PAN.
Conclusion:The obtained results indicate that structural modification occurred in PAN molecule due to photolytic degradation. This article sheds light on the mechanisms for the formation of degradation products for CLP and PAN. A linear gradient mode of elution was used for separation of CLP, PAN and their degradants on a C18 column using a PDA detector. The developed and validated method was used for the analysis of marketed tablets of CLP and PAN in combination.
Keywords: RP-HPLC; Mass Spectrometry; Clopidogrel; Pantoprazole Sodium; Structural Elucidation; Forced Degradation Products
Copyright: © 2018 Jinesh Bahubali Nagavi and Bannimath Gurupadayya. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.