Identification and characterization of potential impurities of valsartan, AT1 receptor antagonist.
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).
Sampath
A
A
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, AP, India.
Reddy
A Raghupathi
AR
Yakambaram
B
B
Thirupathi
A
A
Prabhakar
M
M
Reddy
P Pratap
PP
Reddy
V Prabhakar
VP
D047228:Angiotensin II Type 1 Receptor Blockers / Q000032:analysis / Q000737:chemistry; D000959:Antihypertensive Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy / Q000379:methods*; D013058:Mass Spectrometry / Q000379:methods; D013055:Spectrophotometry, Infrared / Q000379:methods; D013777:Tetrazoles / Q000032:analysis* / Q000737:chemistry; D014633:Valine / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D000068756:Valsartan
D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine