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Method for determining metoprolol tartrate and tablet impurities by ultra-high performance liquid chromatography

A technology of metoprolol tartrate and ultra-high performance liquid phase, which is applied in the field of analytical chemistry and can solve problems such as inability to separate and detect

Active Publication Date: 2020-10-23
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The flow rate is 1ml / min, the detection wavelength is 275nm, the injection volume is 20μl, and the external standard method is used for the detection of impurities; but the above three methods cannot simultaneously separate and detect the 13 impurities described above

Method used

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  • Method for determining metoprolol tartrate and tablet impurities by ultra-high performance liquid chromatography
  • Method for determining metoprolol tartrate and tablet impurities by ultra-high performance liquid chromatography
  • Method for determining metoprolol tartrate and tablet impurities by ultra-high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The instrument and chromatographic conditions adopted are as follows:

[0038] (1) Ultra-high performance liquid chromatography: Waters UPLC H-class

[0039] Detector: PDA

[0040] Chromatographic Workstation: Empower

[0041] (2) Chromatographic column: WatersACQUITY BEH C18 column (1.7μm, 2.1mm×100mm)

[0042] (3) Mobile phase A: 0.02 mol / L sodium dihydrogen phosphate, 2% glacial acetic acid mixed buffer solution (pH=5.5) and acetonitrile in a volume ratio of 97:3. Mobile phase B phase: 0.02mol / L sodium dihydrogen phosphate, 2% glacial acetic acid mixed buffer solution (pH=5.5) and acetonitrile in a volume ratio of 30:70.

[0043] (4) Detection conditions

[0044] The mobile phases A and B are eluted according to the following gradient ratios;

[0045] Mobile phase flow rate: 0.4ml / min;

[0046] Column temperature: 35°C

[0047] Detection wavelength: 275nm

[0048] Injection volume: 2μl

[0049] Gradient table: 0 minutes to 3 minutes, mobile phase A is 100%...

Embodiment 2

[0069] The instrument and chromatographic conditions adopted are as follows:

[0070] (1) Ultra-high performance liquid chromatography: Waters UPLC H-class

[0071] Detector: PDA

[0072] Chromatography Workstation: Empower

[0073] (2) Chromatographic column: Waters ACQUITY BEH C18 column (1.7μm, 2.1mm×100mm)

[0074] (3) Mobile phase A phase: 0.015mol / L sodium dihydrogen phosphate, 1.8% glacial acetic acid mixed buffer solution (pH=5.3) and acetonitrile in a volume ratio of 97:3. Mobile phase B phase: 0.015mol / L sodium dihydrogen phosphate, 1.8% glacial acetic acid mixed buffer solution (pH=5.3) and acetonitrile in a volume ratio of 30:70.

[0075] (4) Detection conditions

[0076] The mobile phases A and B are eluted according to the following gradient ratios;

[0077] Mobile phase flow rate: 0.38ml / min;

[0078] Column temperature: 30°C

[0079] Detection wavelength: 273nm

[0080] Injection volume: 1μl

[0081] Gradient table: 0 minutes to 3 minutes, mobile pha...

Embodiment 3

[0086] The instrument and chromatographic conditions adopted are as follows:

[0087] (1) Ultra-high performance liquid chromatography: Waters UPLC H-class

[0088] Detector: PDA

[0089] Chromatography Workstation: Empower

[0090] (2) Chromatographic column: WatersACQUITY BEH C18 column (1.7μm, 2.1mm×100mm)

[0091] (3) Mobile phase A: 0.025 mol / L sodium dihydrogen phosphate, 2.2% glacial acetic acid mixed buffer solution (pH=5.7) and acetonitrile in a volume ratio of 97:3. Mobile phase B phase: 0.025mol / L sodium dihydrogen phosphate, 2.2% glacial acetic acid mixed buffer solution (pH=5.7) and acetonitrile in a volume ratio of 30:70.

[0092] (4) Detection conditions

[0093] The mobile phases A and B are eluted according to the following gradient ratios;

[0094] Mobile phase flow rate: 0.42ml / min;

[0095] Column temperature: 40°C

[0096] Detection wavelength: 277nm

[0097] Injection volume: 5μl

[0098] Gradient table: 0 minutes to 3 minutes, mobile phase A i...

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Abstract

The invention belongs to the field of analytical chemistry, in particular to a method for determining metoprolol tartrate and tablet impurities by ultra-high performance liquid chromatography. According to the method, gradient elution is carried out by adopting a Waters ultra-high performance liquid chromatograph and a chromatographic column taking octadecylsilane chemically bonded silica as a filler, taking a mixed buffer solution and acetonitrile in a volume ratio of 97: 3 as a mobile phase A and taking the mixed buffer solution and acetonitrile in a volume ratio of 30: 70 as a mobile phaseB. According to the method, 11 known impurities recorded in pharmacopeias can be completely separated and detected at the same time; and in addition, other impurities, especially impurities Q and maltol, of metoprolol tartrate and tablets thereof can be separated and detected through the method, it can be more easily, conveniently, efficiently and accurately guaranteed that the quality of metoprolol tartrate and tablets is controllable, and finally the safety of products is determined.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for measuring metoprolol tartrate and sheet impurities with ultra-high performance liquid chromatography. Background technique [0002] Metoprolol Tartrate, chemical name (±)-1-isopropylamino-3-[4-(2-methoxyethyl)phenoxy]-2-propanol L(+)- Tartrate, its molecular formula is (C15H25NO3)2·C4H6O6, its molecular weight is 684.82, its CAS number is 56392-17-7, and its structural formula is shown in the following formula (a) compound. [0003] [0004] Metoprolol tartrate is a selective beta-1 adrenoceptor blocker. On April 18, 1975, Metoprolol tartrate tablets were launched in Sweden by AstraZeneca, with the trade name Seloken and specifications of 50mg and 100mg. It is mainly used in the treatment of hypertension, angina pectoris, myocardial infarction and other diseases. During the synthesis of metoprolol tartrate, some related process impurities or degradation impu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/027G01N2030/065
Inventor 杨琪刘燕王静刘彩霞王丽丽刘延新杨帅刘亚芳国璐路
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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