Identification of a Degradation Product in Stressed Tablets of Olmesartan Medoxomil by the Complementary Use of HPLC Hyphenated Techniques

Overview

Journal J Pharm Biomed Anal

Specialty Chemistry

Date 2008 Apr 9

PMID 18394840

Citations 8

Authors

Tomonori Murakami

Hidetoshi Konno

Naoto Fukutsu

Michinobu Onodera

Takao Kawasaki

Fumiyo Kusu

Affiliations

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Abstract

An unknown degradation product (DP-1) increased in olmesartan medoxomil (OLM) tablets stored at 40 degrees C/75% r.h., reaching 0.72% after 6 months. The molecular weight and fragment information obtained by LC-MS suggested that DP-1 was a dehydrated dimer of olmesartan (OL) and the presence of ester carbonyl group was indicated by solvent-elimination LC-IR analysis. LC-(1)H NMR confirmed the structure of DP-1 as an esterified dimer of OL. Rapid and accurate identification of the degradation product was achieved by the complementary use of HPLC hyphenated techniques without complicated isolation or purification processes.

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