Title:
METHOD FOR DETECTING RELATED SUBSTANCE MPEG IN BENZONATATE
Document Type and Number:
WIPO Patent Application WO/2022/156241
Kind Code:
A1
Abstract:
Disclosed is a method for detecting the related substance MPEG in benzonatate. The detection method is a method of high-performance liquid chromatography combined with evaporative light scattering detection and comprises the following specific detection steps: 1) preparing MPEG standard solutions with different concentrations, and establishing a standard curve of MPEG solution concentration vs. peak area by means of high-performance liquid chromatography; 2) dissolving a benzonatate sample in a mixed solution of acetonitrile and water to prepare a benzonatate sample solution; and (3) determining the peak area of the benzonatate sample solution in step (2) by means of high-performance liquid chromatography, and then fitting same to the standard curve in step (1) to obtain the concentration of MPEG in the benzonatate sample solution. The detection method can not only rapidly and accurately detect the content of the related substance MPEG in a benzonatate sample, but also has a low limit of detection, and the detection method is suitable for large-scale detection of samples during actual production.
Inventors:
TAN XIANG (CN)
NIE LEI (CN)
JIANG CHUN LAI (CN)
GAO YONG (CN)
XIONG CHUAN (CN)
HU LI (CN)
CHEN HUI (CN)
NIE LEI (CN)
JIANG CHUN LAI (CN)
GAO YONG (CN)
XIONG CHUAN (CN)
HU LI (CN)
CHEN HUI (CN)
Application Number:
PCT/CN2021/118400
Publication Date:
July 28, 2022
Filing Date:
September 15, 2021
Export Citation:
Assignee:
HUMANWELL PURACAP PHARMACEUTICALS WUHAN CO LTD (CN)
International Classes:
G01N30/02; G01N30/74
Foreign References:
| CN112903860A | 2021-06-04 | |||
| CN104927041A | 2015-09-23 | |||
| CN101133322A | 2008-02-27 | |||
| US20130096191A1 | 2013-04-18 |
Other References:
SAFAA M. KISHK, ISMAIL SALAMA, SAMIA MOSTAFA, MOHAMED EL-SADEK: "Stability-Indicating Chromatographic Method for the Determination of Benzonatate, Diphenhydramine, Guaifenesin, and Phenylephrine", JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, vol. 37, no. 5, 16 March 2014 (2014-03-16), US , pages 726 - 747, XP009538432, ISSN: 1082-6076, DOI: 10.1080/10826076.2012.758140
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