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A Stability-Indicating LC-MS Method for Determination of Perindopril and its Process Related Impurities

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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.

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KSU authors appreciate support of the Deanship of Scientific Research at the King Saud University (KSU) for Research Group RGP-1437 – 003.

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Correspondence to Nadavala Siva Kumar.

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Kumar, N.S., Sreenivasulu, V., Ramachandra, B. et al. A Stability-Indicating LC-MS Method for Determination of Perindopril and its Process Related Impurities. Pharm Chem J 52, 378–383 (2018).

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