Title:
ANALYSIS METHOD FOR DETERMINING SUBSTANCE RELATED TO LUBIPROSTONE TEST SAMPLE
Document Type and Number:
WIPO Patent Application WO/2020/125027
Kind Code:
A1
Abstract:
Provided is an analysis method for determining a Lubiprostone-related substance, wherein in the method, a Lubiprostone compound, a compound of formula II, a compound of formula III, a compound of formula IV and a compound of formula V are separated and determined using normal-phase high-performance liquid chromatography. The method prevents the problem of traditional analysis methods in which Lubiprostone is bimodal. The method is conducive to the calculation of related substance correction factors and the accurate quantification of related substances, and is an analysis method conducive to the quality control of Lubiprostone.
Inventors:
LI JINGJING (CN)
LIN PING (CN)
WU JING (CN)
WANG HUAPING (CN)
LAN GONGJIAN (CN)
CHAI YUZHU (CN)
XU DAN (CN)
ZHU CHUNXIA (CN)
TIAN ZHOUSHAN (CN)
LIN PING (CN)
WU JING (CN)
WANG HUAPING (CN)
LAN GONGJIAN (CN)
CHAI YUZHU (CN)
XU DAN (CN)
ZHU CHUNXIA (CN)
TIAN ZHOUSHAN (CN)
Application Number:
PCT/CN2019/100185
Publication Date:
June 25, 2020
Filing Date:
August 12, 2019
Export Citation:
Assignee:
NANJING CHIA TAI TIANQING PHARMACEUTICAL CO LTD (CN)
International Classes:
B01D15/42; A61P1/10; G01N30/02
Foreign References:
| CN102020625A | 2011-04-20 | |||
| CN104072433A | 2014-10-01 | |||
| CN105985309A | 2016-10-05 | |||
| US20120270931A1 | 2012-10-25 | |||
| US20130184476A1 | 2013-07-18 |
Other References:
LIU, YUNDONG ET AL.: "Determination of the Related Substances in Lubiprostone by HPLC", CHEMICAL INDUSTRY TIMES, vol. 32, no. 12, 26 December 2018 (2018-12-26), ISSN: 1002-154X
Attorney, Agent or Firm:
NANJING LE YU ZHI XING PATENT AGENCY FIRM (GENERAL PARTENERSHIP) (CN)
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