CN114651177A - 一种羧甲司坦原料及其制剂的质量控制方法及其应用 - Google Patents

一种羧甲司坦原料及其制剂的质量控制方法及其应用 Download PDF

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Publication number
CN114651177A
CN114651177A CN202080073423.XA CN202080073423A CN114651177A CN 114651177 A CN114651177 A CN 114651177A CN 202080073423 A CN202080073423 A CN 202080073423A CN 114651177 A CN114651177 A CN 114651177A
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China
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carbocisteine
impurity
impurities
solution
phosphate
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CN202080073423.XA
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Inventor
程志伟
吴健辉
孙金鑫
顾云
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Guangdong Xianqiang Pharmaceutical Co ltd
Guangdong Yi Yi Pharmaceutical Ltd By Share Ltd
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO Ltd
Guangdong Zhongsheng Pharmaceutical Co Ltd
Original Assignee
Guangdong Xianqiang Pharmaceutical Co ltd
Guangdong Yi Yi Pharmaceutical Ltd By Share Ltd
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO Ltd
Guangdong Zhongsheng Pharmaceutical Co Ltd
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Publication of CN114651177A publication Critical patent/CN114651177A/zh
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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
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • 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
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample

Abstract

本发明公开了一种通过高效液相色谱法分离测定羧甲司坦及其杂质的方法，所述测定方法采用十八烷基硅烷键合硅胶为填充剂的色谱柱，其检测条件如下：色谱条件：色谱柱为十八烷基硅烷键合硅胶色谱柱，流动相为磷酸盐—离子对缓冲液，流动相pH为1.6～2.0，检测波长为215nm。本发明方法精密度高，重复性好，回收率高，可以广泛用于不同来源的羧甲司坦原料药及其对应制剂的质量检测。

Description

PCT国内申请，说明书已公开。

Claims (18)

  1. PCT国内申请，权利要求书已公开。
CN202080073423.XA 2019-11-11 2020-11-10 一种羧甲司坦原料及其制剂的质量控制方法及其应用 Pending CN114651177A (zh)

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CN2019110925463 2019-11-11
CN201911092546.3A CN112782327B (zh) 2019-11-11 2019-11-11 一种液相色谱法分离测定羧甲司坦及其杂质的方法
PCT/CN2020/127866 WO2021093733A1 (zh) 2019-11-11 2020-11-10 一种羧甲司坦原料及其制剂的质量控制方法及其应用

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CN112782327B (zh) * 2019-11-11 2022-02-01 广东逸舒制药股份有限公司 一种液相色谱法分离测定羧甲司坦及其杂质的方法
CN114166963B (zh) * 2021-11-22 2023-06-30 北京悦康科创医药科技股份有限公司 一种头孢呋辛钠中杂质的二维检测方法
CN115436556B (zh) * 2022-09-20 2024-04-19 常州佳德医药科技有限公司 一种利用反相液相色谱法测定硼酸酯类化合物纯度的方法及应用
CN116008439B (zh) * 2023-02-20 2023-10-27 山东绿叶制药有限公司 一种检测2,6-二氧杂螺[4,5]癸烷类化合物或其盐中杂质的方法
CN117129596B (zh) * 2023-08-29 2024-04-23 首都医科大学附属北京儿童医院 基于高效液相技术的STING激动剂环二核苷酸cGAMP定量检测方法的建立

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105181859A (zh) * 2015-10-12 2015-12-23 南京天翔医药科技有限公司 对乙酰氨基酚注射液中盐酸半胱氨酸及降解产物胱氨酸的测定方法
CN106680386A (zh) * 2016-12-07 2017-05-17 万全万特制药（厦门）有限公司 液相色谱法分离测定羧甲司坦原料药和制剂的有关物质
CN109633040A (zh) * 2019-02-26 2019-04-16 山东博济医药科技有限公司 一种羧甲司坦含量测定方法
CN112782327A (zh) * 2019-11-11 2021-05-11 广东逸舒制药股份有限公司 一种液相色谱法分离测定羧甲司坦及其杂质的方法

Family Cites Families (1)

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Publication number Priority date Publication date Assignee Title
EP3668977A4 (en) * 2017-08-18 2021-04-21 Modernatx, Inc. HPLC ANALYTICAL PROCESSES

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105181859A (zh) * 2015-10-12 2015-12-23 南京天翔医药科技有限公司 对乙酰氨基酚注射液中盐酸半胱氨酸及降解产物胱氨酸的测定方法
CN106680386A (zh) * 2016-12-07 2017-05-17 万全万特制药（厦门）有限公司 液相色谱法分离测定羧甲司坦原料药和制剂的有关物质
CN109633040A (zh) * 2019-02-26 2019-04-16 山东博济医药科技有限公司 一种羧甲司坦含量测定方法
CN112782327A (zh) * 2019-11-11 2021-05-11 广东逸舒制药股份有限公司 一种液相色谱法分离测定羧甲司坦及其杂质的方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
李可鹏 等: "羧甲司坦中杂质的分离和鉴定", 药物分析杂志, vol. 34, no. 4, pages 707 - 710 *

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