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Method for detecting metabolite of ilaprazole in urine

A technology of metabolites and urine, applied in the field of detection of metabolites of ilaprazole in urine, can solve problems such as insufficient

Active Publication Date: 2011-04-20
LIVZON PHARM GRP INC
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, for the exact elucidation of the metabolite structure, only MS data is not enough

Method used

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  • Method for detecting metabolite of ilaprazole in urine
  • Method for detecting metabolite of ilaprazole in urine
  • Method for detecting metabolite of ilaprazole in urine

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Embodiment 1

[0041] 1. Drugs and reagents

[0042] Ilaprazole (5 mg enteric-coated tablets) and ilaprazole sulfide (≥99.5%) were provided by Livzon Pharmaceutical Group Co., Ltd. (Zhuhai, China). HPLC grade acetonitrile was purchased from Dikma Company (Guangzhou, China). Deuterated acetonitrile for nuclear magnetic resonance (NMR) was purchased from Sigma-Aldrich Chemie GmbH (Steinheim, Germany). All aqueous solutions in the test were pure water prepared by Milli-Q water system (Millipore, Bedford, MA, USA). Other chemical reagents of analytical grade were purchased from Chemical Reagent Factory of Hunan Normal University (Changsha, Hunan, China).

[0043] 2. Subjects

[0044] Six healthy volunteers participated in this study, all of whom were non-smokers and had no history of significant medical diseases. This study was approved by the Ethics Committee of Xiangya School of Medicine, Central South University (Hunan, China). All subjects signed the informed consent, and underwent phys...

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Abstract

The invention provides a method for detecting metabolite of ilaprazole in urine. The method comprises the following steps of: (1) adding Na2CO3 solution into the urine for precipitation, adding dichloromethane solution containing 0.05 mol / L ammonium salt into supernatant for extraction, and drying a solvent through an organic phase to obtain a sample; (2) performing high performance liquid chromatography-mass spectrometry coupling analysis on the sample; and (3) performing high performance liquid chromatography-nuclear magnetic resonance coupling analysis on the sample. The ilaprazole is a novel proton pump inhibitor for treating peptic ulcer. In the method, a high performance liquid chromatography-mass spectrometry coupling analyzer (HPLC-MS / MS) and a stopped-flow high performance liquidchromatography-nuclear magnetic resonance (HPLC-NMR) test are adopted to clarify the structure of the ilaprazole metabolite in the urine of a human body. Four sulfuration metabolites are identified according to MS / MS and NMR data of the existing standard substances of the ilaprazole and the metabolite of the ilaprazole. A result shows that the method can be widely applied to the quick detection and identification of the metabolite of the ilaprazole.

Description

technical field [0001] The invention belongs to the field of drug detection and analysis, in particular to a method for detecting metabolites of ilaprazole in urine. Background technique [0002] Ilaprazole (2-[(4-methoxy-3-methyl)-2-pyridyl]methylsulfonyl-5-(1H-pyrrol-1-yl)-1H-benzimidazole, formerly known as IY81149) is a new proton pump inhibitor developed by Il Yang Pharmaceutical Co., Ltd. (Seoul, South Korea) for the treatment of peptic ulcer. Many early animal (such as mice, rats, dogs and pigs) in vitro studies showed that ilaprazole significantly inhibited the development of reflux esophagitis and gastric juice secretion in a dose-dependent manner, and had significant effects on the cardiovascular system and autonomic nervous system of animals. or smooth muscle function was minimal, indicating that ilaprazole is an effective and very safe antiulcer drug. Clinical studies have shown that in patients with gastroesophageal reflux disease, taking 20 mg ilaprazole can ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/72G01N30/78G01N30/36G01N30/60
Inventor 施树云周淦张伟周宏灏胡海棠谭竟
Owner LIVZON PHARM GRP INC
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