Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques.
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.
Murakami
Tomonori
T
Analytical and Quality Evaluation Research Laboratories, Daiichi-Sankyo Co. Ltd., 1-12-1 Shinomiya, Hiratsuka, Kanagawa 254-0014, Japan. murakami.tomonori.a5@daiichisankyo.co.jp
Konno
Hidetoshi
H
Fukutsu
Naoto
N
Onodera
Michinobu
M
Kawasaki
Takao
T
Kusu
Fumiyo
F
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D007093:Imidazoles / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy; D000068557:Olmesartan Medoxomil; D021241:Spectrometry, Mass, Electrospray Ionization; D013607:Tablets; D013777:Tetrazoles / Q000737:chemistry*
D007093:Imidazoles; D013607:Tablets; D013777:Tetrazoles; D000068557:Olmesartan Medoxomil