A Stability-Indicating LC-MS Method for Determination of Perindopril and its Process Related Impurities
- Authors: Kumar N.S.1, Sreenivasulu V.2, Ramachandra B.3, Asif M.1, Ibrahim A.A.1
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Affiliations:
- Department of Chemical Engineering, King Saud University
- Analytical Development Laboratory, Cipla Limited, Virgonagar
- Department of Chemistry, Government College for Men (A)
- Issue: Vol 52, No 4 (2018)
- Pages: 378-383
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245197
- DOI: https://doi.org/10.1007/s11094-018-1825-2
- ID: 245197
Cite item
Abstract
Perindopril erbumine belongs to the member of angiotensin-converting enzyme inhibitors group used in the treatment of heart failure and hypertension. Asimple and highly sensitive LC-MS method has been developed for the simultaneous determination of three process-related impurities (L-norvaline, L-norvaline ethyl ester HCl, and (S)-indoline-2-carboxylic acid) in perindopril. Samples were separated using 5 mM ammonium formate (A) and acetonitrile/methanol (B) as the mobile phase on a Symmetry C18 column (75 mm × 4.6 mm, 3.5 μm) using gradient elution mode at a flow rate of 0.6 mL/min. The proposed method was validated as per ICH guidelines and can be used for quality testing of perindopril and determining its process-related impurities in pharmaceuticals.
About the authors
Nadavala Siva Kumar
Department of Chemical Engineering, King Saud University
Author for correspondence.
Email: shivanadavala@gmail.com
Saudi Arabia, Riyadh, 11421
Vudagandla Sreenivasulu
Analytical Development Laboratory, Cipla Limited, Virgonagar
Email: shivanadavala@gmail.com
India, (Karnataka), Bangalore
Bondigalla Ramachandra
Department of Chemistry, Government College for Men (A)
Email: shivanadavala@gmail.com
India, Kadapa, Andhra Pradesh, 516004
Mohammad Asif
Department of Chemical Engineering, King Saud University
Email: shivanadavala@gmail.com
Saudi Arabia, Riyadh, 11421
Ahmed A. Ibrahim
Department of Chemical Engineering, King Saud University
Email: shivanadavala@gmail.com
Saudi Arabia, Riyadh, 11421