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A validated chiral HPLC method for the enantiomeric purity of alogliptin benzoate | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X

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Abstract

A validated chiral HPLC method for the enantiomeric purity of alogliptin benzoate

Author(s): G. Srinivasa Rao, K. Mallesh, G. Vijay Kumar, Ch. Surekha, B. Venugopala Rao

An isocratic chiral stationary phase high-performance liquid chromatographic (CSP-HPLC) method has been developed and validated for the quantitation of (S)-isomer in Alogliptin Benzoate. Separation was achieved with a Lux cellulose 2 (250×4.6mm, 5μm) column. The ratio of ethanol and diethyl amine in the mobile phase were optimized to obtain the best separation. UV detection was performed at 230 nm. The described method is linear over a range of LOQ – 1.5 μg/mL of (S)-isomer. The mean recovery of (S)-isomer was found to be in the range of 100–102%. The method is simple, rapid, accurate, selective and precise, useful in the quality control of bulk manufacturing.


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