Identification and characterization of potential impurities of valsartan,AT1 receptor antagonist |
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| Authors: | A Sampath A Raghupathi Reddy B Yakambaram A Thirupathi M Prabhakar P Pratap Reddy V Prabhakar Reddy |
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| Affiliation: | 1. Department of Research and Development, Integrated Product Development, Innovation Plaza, Dr. Reddy''s Laboratories Ltd., Survey Nos. 42, 45, 46 & 54, Bachupally, Qutubullapur, R.R. Dist-500072, A.P., India;2. Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, A.P., India |
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| Abstract: | Five impurities (related substances) were detected during the impurity profile study of an antihypertensive drug substance, valsartan. A simple gradient high performance liquid chromatographic method (HPLC) and liquid chromatography–mass spectrometry (LC–MS) were used for the detection. Based on the spectral data (IR, NMR and MS) followed by synthesis, these impurities were characterized as (S)-N-(1-carboxy-2-methylprop-1-yl)-N-2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amine (impurity I); (S)-N-(1-carboxy-2-methylprop-1-yl)-N-(5-phenylthio)pentanoyl-N-2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amine (impurity II); (S)-N-(1-carboxy-2-methylprop-1-yl)-N-(5-phenyl)pentanoyl-N-2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amine (impurity III); (S)-N-(1-carboxy-2-methylprop-1-yl)-N-4-pentenoyl-N-2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amine (impurity IV); (S)-N-(1-carboxy-2-methylprop-1-yl)-N-(5-hydroxy)pentanoyl-N-2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]amine (impurity V). |
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| Keywords: | Valsartan impurities Desulfurization Spectroscopy Identification Characterization |
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