CN115372487B - 盐酸格拉司琼中杂质e的hplc测定方法 - Google Patents
盐酸格拉司琼中杂质e的hplc测定方法 Download PDFInfo
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- CN115372487B CN115372487B CN202110541739.3A CN202110541739A CN115372487B CN 115372487 B CN115372487 B CN 115372487B CN 202110541739 A CN202110541739 A CN 202110541739A CN 115372487 B CN115372487 B CN 115372487B
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- impurity
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- ammonium acetate
- granisetron hydrochloride
- acetonitrile
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information
- G01N30/8679—Target compound analysis, i.e. whereby a limited number of peaks is analysed
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N2030/042—Standards
- G01N2030/047—Standards external
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
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- Engineering & Computer Science (AREA)
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- Treatment Of Liquids With Adsorbents In General (AREA)
Abstract
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CN202110541739.3A CN115372487B (zh) | 2021-05-18 | 2021-05-18 | 盐酸格拉司琼中杂质e的hplc测定方法 |
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CN202110541739.3A CN115372487B (zh) | 2021-05-18 | 2021-05-18 | 盐酸格拉司琼中杂质e的hplc测定方法 |
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CN115372487A CN115372487A (zh) | 2022-11-22 |
CN115372487B true CN115372487B (zh) | 2023-10-10 |
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Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2124163A1 (es) * | 1995-03-01 | 1999-01-16 | Smithkline Beecham Plc | Un nuevo procedimiento para preparar compuestos farmaceuticamente activos. |
WO2003080606A1 (en) * | 2002-03-26 | 2003-10-02 | Laboratorios Vita, S.A. | Process for preparing a pharmaceutically active compound (granisetron) |
CN1451660A (zh) * | 2002-04-19 | 2003-10-29 | 浙江海正药业股份有限公司 | 一种制备格拉司琼及其盐的方法 |
WO2007054784A1 (en) * | 2005-11-10 | 2007-05-18 | Orchid Chemicals & Pharmaceuticals Limited | An improved process for the preparation of granisetron hydrochloride |
WO2007088557A1 (en) * | 2006-02-01 | 2007-08-09 | Natco Pharma Limited | Process for highly pure crystalline granisetron base |
CN102131506A (zh) * | 2008-08-19 | 2011-07-20 | 台湾神隆股份有限公司 | 盐酸格拉司琼的多晶型和其制备方法 |
CN103415286A (zh) * | 2010-11-11 | 2013-11-27 | 阿克伦分子有限公司 | 用于治疗疼痛的化合物和方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7060841B2 (en) * | 2003-06-03 | 2006-06-13 | Chemagis Ltd. | Process for preparing 1-methylindazole-3-carboxylic acid |
US7844266B2 (en) * | 2003-09-30 | 2010-11-30 | Intel Corporation | Wireless network roaming timer method and apparatus |
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2021
- 2021-05-18 CN CN202110541739.3A patent/CN115372487B/zh active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2124163A1 (es) * | 1995-03-01 | 1999-01-16 | Smithkline Beecham Plc | Un nuevo procedimiento para preparar compuestos farmaceuticamente activos. |
WO2003080606A1 (en) * | 2002-03-26 | 2003-10-02 | Laboratorios Vita, S.A. | Process for preparing a pharmaceutically active compound (granisetron) |
CN1451660A (zh) * | 2002-04-19 | 2003-10-29 | 浙江海正药业股份有限公司 | 一种制备格拉司琼及其盐的方法 |
WO2007054784A1 (en) * | 2005-11-10 | 2007-05-18 | Orchid Chemicals & Pharmaceuticals Limited | An improved process for the preparation of granisetron hydrochloride |
WO2007088557A1 (en) * | 2006-02-01 | 2007-08-09 | Natco Pharma Limited | Process for highly pure crystalline granisetron base |
CN102131506A (zh) * | 2008-08-19 | 2011-07-20 | 台湾神隆股份有限公司 | 盐酸格拉司琼的多晶型和其制备方法 |
CN103415286A (zh) * | 2010-11-11 | 2013-11-27 | 阿克伦分子有限公司 | 用于治疗疼痛的化合物和方法 |
Non-Patent Citations (5)
Title |
---|
Development of sublingual spray formulation containing ondansetron hydrochloride dihydrate;Ashish Chokshi 等;Journal of Drug Delivery Science and Technology;第53卷;第1-6页 * |
Efficient Syntheses of exo-Granisetron Hydrochloride and other Potential Impurities Present in Granisetron Hydrochloride, an Anti-Emetic Drug;Eda V.R. Vishnu 等;Letters in Organic Chemistry;第8卷(第10期);第711-727页 * |
HPLC测定盐酸格拉司琼葡萄糖注射液中盐酸格拉司琼含量及有关物质;李江 等;应用化工;第40卷(第04期);第711-713页 * |
Hydrophilic interaction liquid chromatography in analysis ofgranisetron HCl and its related substances. Retention mechanismsand method development;Jelena Maksi´c 等;Journal of Pharmaceutical and Biomedical Analysis;第123卷;第93-103页 * |
国家药典委员会 编.《中华人民共和国药典2015年版一部》.中国医药科技出版社,2015,第1056-1057页. * |
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Effective date of registration: 20230912 Address after: No. 66, West Section of Kelin Road, Chengdu Cross Strait Science and Technology Industry Development Park, Wenjiang District, Chengdu, 610000, Sichuan Applicant after: Chengdu Beite Danuo Pharmaceutical Co.,Ltd. Address before: No. 15 high tech Zone Gaopeng road in Chengdu city of Sichuan Province in 610041 Applicant before: Chengdu Beite Pharmaceutical Co.,Ltd. Applicant before: Chengdu Beite Danuo Pharmaceutical Co.,Ltd. |
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