The novel acid degradation products of losartan: Isolation and characterization using Q-TOF, 2D-NMR and FTIR.

Autor: Kumar Pandey A; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Rapolu R; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Raju ChK; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Sasalamari G; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Kumar Goud S; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Awasthi A; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India. Electronic address: axa@usp.org., Navalgund SG; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India., Surendranath KV; Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad 500078, India.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2016 Feb 20; Vol. 120, pp. 65-71. Date of Electronic Publication: 2015 Nov 28.
DOI: 10.1016/j.jpba.2015.11.037
Abstrakt: Forced degradation of losartan potassium in acidic condition resulted into three potential unknown impurities. These unknown degradation products marked as LD-I, LD-II and LD-III were analyzed using a new reverse-phase high performance liquid chromatography (HPLC), eluting at 3.63, 3.73 and 3.91 relative retention times with respect to losartan potassium (LOS) peak. All three were isolated from reaction mass using preparative HPLC and their structures were elucidated using LC-MS/MS, multidimensional NMR and FTIR spectroscopic techniques, as 5(2),11(2)-dibutyl-5(4),11(4)-dichloro-1(1)H,5(1)H,7(1)H,11(1)H-1(5,1),7(1,5)-ditetrazola-5,11(1,5)-diimidazola-2,8(1,2),3,9(1,4)-tetrabenzenacyclododecaphane,(Z)-5(2),11(2)-dibutyl-5(4),11(4)-dichloro-1(1)H,5(1)H,7(2)H,11(1)H-1(5,1),7(2,5)-ditetrazola-5,11(1,5)-diimidazola-2,8(1,2),3,9(1,4)-tetrabenzenacyclododecaphane, and 5(2),11(2)-dibutyl-5(4),11(4)-dichloro-1(2)H,5(1)H,7(2)H,11(1)H-1(5,2),7(2,5)-ditetrazola-5,11(1,5)-diimidazola-2,8(1,2),3,9(1,4)-tetrabenzenacyclododecaphane, respectively. To best of our knowledge, all three degradation products are novel impurities which are not discussed at any form of publication yet.
(Copyright © 2015. Published by Elsevier B.V.)
Databáze: MEDLINE
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