CN108072717B - 一种精氨酸溶液的检测方法 - Google Patents
一种精氨酸溶液的检测方法 Download PDFInfo
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- CN108072717B CN108072717B CN201810117852.7A CN201810117852A CN108072717B CN 108072717 B CN108072717 B CN 108072717B CN 201810117852 A CN201810117852 A CN 201810117852A CN 108072717 B CN108072717 B CN 108072717B
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- 239000004475 Arginine Substances 0.000 title claims abstract description 62
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 title claims abstract description 62
- 238000000034 method Methods 0.000 title claims abstract description 24
- 239000012535 impurity Substances 0.000 claims abstract description 60
- 238000001514 detection method Methods 0.000 claims abstract description 43
- 239000013558 reference substance Substances 0.000 claims abstract description 41
- 239000000243 solution Substances 0.000 claims abstract description 30
- 239000012086 standard solution Substances 0.000 claims abstract description 28
- 238000004128 high performance liquid chromatography Methods 0.000 claims abstract description 13
- 238000012417 linear regression Methods 0.000 claims abstract description 11
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical group CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 13
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 12
- 239000008213 purified water Substances 0.000 claims description 12
- IKIABDZHSNNOSK-UHFFFAOYSA-N 2-amino-4,5,6,7-tetrahydro-1h-1,3-diazepine-7-carboxylic acid Chemical compound NC1=NCCCC(C(O)=O)N1 IKIABDZHSNNOSK-UHFFFAOYSA-N 0.000 claims description 10
- 239000007853 buffer solution Substances 0.000 claims description 10
- 238000010828 elution Methods 0.000 claims description 10
- HRQDCDQDOPSGBR-UHFFFAOYSA-M sodium;octane-1-sulfonate Chemical compound [Na+].CCCCCCCCS([O-])(=O)=O HRQDCDQDOPSGBR-UHFFFAOYSA-M 0.000 claims description 10
- YCCMTCQQDULIFE-UHFFFAOYSA-N 3-aminopiperidine-2-one Chemical compound NC1CCCNC1=O YCCMTCQQDULIFE-UHFFFAOYSA-N 0.000 claims description 7
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 7
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 6
- 239000000377 silicon dioxide Substances 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 4
- 230000035945 sensitivity Effects 0.000 abstract description 7
- 239000000523 sample Substances 0.000 description 11
- 239000000047 product Substances 0.000 description 7
- 239000007788 liquid Substances 0.000 description 5
- 238000004809 thin layer chromatography Methods 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 4
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000004458 analytical method Methods 0.000 description 3
- 238000004587 chromatography analysis Methods 0.000 description 3
- MWUXSHHQAYIFBG-UHFFFAOYSA-N Nitric oxide Chemical compound O=[N] MWUXSHHQAYIFBG-UHFFFAOYSA-N 0.000 description 2
- XFXIJSRNFKHZFW-UHFFFAOYSA-N [Na].CCCCCCCC Chemical compound [Na].CCCCCCCC XFXIJSRNFKHZFW-UHFFFAOYSA-N 0.000 description 2
- 239000012488 sample solution Substances 0.000 description 2
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003797 essential amino acid Substances 0.000 description 1
- 235000020776 essential amino acid Nutrition 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 230000036299 sexual function Effects 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
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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
-
- 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
-
- 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
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/36—Control of physical parameters of the fluid carrier in high pressure liquid systems
-
- 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
- G01N30/50—Conditioning of the sorbent material or stationary liquid
- G01N30/52—Physical parameters
- G01N30/54—Temperature
-
- 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
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid 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
- G01N2030/062—Preparation extracting sample from raw material
-
- 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
- G01N2030/8813—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 biological materials
- G01N2030/8818—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 biological materials involving amino acids
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
- Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
Abstract
Description
名称 | 线性方程 | 相关系数 |
精氨酸 | y=5.1951x+6.1656 | r=0.9999 |
杂质1 | y=26.087x+0.8774 | r=0.9999 |
杂质2 | y=26.407x+3.2603 | r=0.9999 |
Claims (6)
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CN201810117852.7A CN108072717B (zh) | 2018-02-06 | 2018-02-06 | 一种精氨酸溶液的检测方法 |
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CN201810117852.7A CN108072717B (zh) | 2018-02-06 | 2018-02-06 | 一种精氨酸溶液的检测方法 |
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CN108072717A CN108072717A (zh) | 2018-05-25 |
CN108072717B true CN108072717B (zh) | 2020-10-23 |
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Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110455955A (zh) * | 2019-08-22 | 2019-11-15 | 精晶药业股份有限公司 | 一种精氨酸中杂质的检测方法 |
CN114965746B (zh) * | 2022-04-24 | 2023-10-03 | 扬子江药业集团广州海瑞药业有限公司 | 门冬氨酸鸟氨酸注射液杂质分析检测方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103048396A (zh) * | 2012-08-31 | 2013-04-17 | 石家庄中硕药业集团有限公司 | 一种精氨酸含量的测定方法 |
CN106596799A (zh) * | 2017-01-20 | 2017-04-26 | 阳泉煤业(集团)有限责任公司 | 通过高效液相色谱检测甘氨酸及其杂质的方法 |
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2018
- 2018-02-06 CN CN201810117852.7A patent/CN108072717B/zh active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103048396A (zh) * | 2012-08-31 | 2013-04-17 | 石家庄中硕药业集团有限公司 | 一种精氨酸含量的测定方法 |
CN106596799A (zh) * | 2017-01-20 | 2017-04-26 | 阳泉煤业(集团)有限责任公司 | 通过高效液相色谱检测甘氨酸及其杂质的方法 |
Non-Patent Citations (2)
Title |
---|
Tandem column for the simultaneous determination of arginine, ibuprofen and related impurities by liquid chromatography;A.L. Huidobro et al.;《Journal of Chromatography A》;20051220;第238-245页 * |
盐酸精氨酸葡萄糖注射液中精氨酸含量及有关物质的HPLC测定;陈妍 等;《山东医药》;20031231;第67页 * |
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Denomination of invention: A detection method for arginine solution Effective date of registration: 20230418 Granted publication date: 20201023 Pledgee: Hebei Ningjin Rural Commercial Bank Co.,Ltd. Pledgor: JING JING PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980038366 |
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Date of cancellation: 20231114 Granted publication date: 20201023 Pledgee: Hebei Ningjin Rural Commercial Bank Co.,Ltd. Pledgor: JING JING PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980038366 |
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Denomination of invention: A detection method for arginine solution Effective date of registration: 20231204 Granted publication date: 20201023 Pledgee: Hebei Ningjin Rural Commercial Bank Co.,Ltd. Pledgor: JING JING PHARMACEUTICAL Co.,Ltd. Registration number: Y2023980069369 |
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