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High performance liquid chromatography detection analysis method for controlling ticagrelor isomer

A high-performance liquid chromatography and ticagrelor technology, applied in the field of pharmaceutical chemical analysis, to achieve the effect of high chiral purity, product stability, and high resolution

Inactive Publication Date: 2015-11-25
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, there are few reports on the detection method of ticagrelor in the prior art. For the optical isomer impurities of ticagrelor, quality control is required during the drug synthesis process

Method used

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  • High performance liquid chromatography detection analysis method for controlling ticagrelor isomer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Instruments and Conditions

[0026] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0027] Chromatographic column: OJ-H (DACEL4.6mm×250mm, 5μm);

[0028] Mobile phase: n-hexane – methanol = 80:20;

[0029] Flow rate: 1.0mL / min;

[0030] Column temperature: room temperature;

[0031] Injection volume: 10μL;

[0032] Detection wavelength: 225nm;

[0033] Experimental procedure

[0034] Weigh 5 mg of ticagrelor and its isomer II respectively, place in a 25 mL volumetric flask, add absolute ethanol

[0035] Dissolve and dilute to the mark, shake well, as a mixed sample solution. And weigh 5 mg of ticagrelor and its enantiomer II respectively, put them in two 25mL volumetric flasks, add absolute ethanol to dissolve and dilute to the scale, shake well, and use it as a qualitative control solution.

[0036] Take each control solution and mixed sample solution respectively, carry out high-performance liquid chromatography analysis according to...

Embodiment 2

[0039] Instruments and Conditions

[0040] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0041] Chromatographic column: OJ-H (DACEL4.6mm×250mm, 5μm);

[0042] Mobile phase: n-hexane – methanol = 85:15;

[0043] Flow rate: 1.0mL / min;

[0044] Column temperature: room temperature;

[0045] Injection volume: 10μL;

[0046] Detection wavelength: 225nm;

[0047] Experimental procedure

[0048] Weigh 5 mg of ticagrelor and its isomer II respectively, place in a 25 mL volumetric flask, add absolute ethanol

[0049] Dissolve and dilute to the mark, shake well, as a mixed sample solution. And weigh 5 mg of ticagrelor and its enantiomer II respectively, put them in two 25mL volumetric flasks, add absolute ethanol to dissolve and dilute to the scale, shake well, and use it as a qualitative control solution.

[0050] Take each control solution and mixed sample solution respectively, carry out high-performance liquid chromatography analysis according to...

Embodiment 3

[0053] Instruments and Conditions

[0054] High performance liquid chromatography: Shimadzu: LC-10ATvp, SPD-M10Avp;

[0055] Chromatographic column: OJ-H (DACEL4.6mm×250mm, 5μm);

[0056] Mobile phase: n-hexane – ethanol = 90:10;

[0057] Flow rate: 1.0mL / min;

[0058] Column temperature: room temperature;

[0059] Injection volume: 10μL;

[0060] Detection wavelength: 225nm;

[0061] Experimental procedure

[0062] Weigh 5 mg of ticagrelor and its isomer II respectively, place in a 25 mL volumetric flask, add absolute ethanol

[0063] Dissolve and dilute to the mark, shake well, as a mixed sample solution. And weigh 5 mg of ticagrelor and its enantiomer II respectively, put them in two 25mL volumetric flasks, add absolute ethanol to dissolve and dilute to the scale, shake well, and use it as a qualitative control solution.

[0064] Take each control solution and mixed sample solution respectively, carry out high-performance liquid chromatography analysis according to ...

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Abstract

The invention discloses a high performance liquid chromatography detection analysis method for controlling a ticagrelor isomer, which employing a cellulose filler a chiral chromatographic column and takes lower paraffin hydrocarbon-lower alcohol as mobile phases, and the method can rapidly separate isomer impurity of ticagrelor.

Description

technical field [0001] The invention relates to a detection method, in particular to a high-performance liquid chromatography detection and analysis method for controlling ticagrelor isomers. The invention belongs to the technical field of pharmaceutical chemical analysis. Background technique [0002] Ticagrelor is a new type of selective small molecule anticoagulant drug developed by AstraZeneca. The structural formula I of ticagrelor: [0003] [0004] I [0005] Its chemical name is: (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorobenzene)cyclopropyl]amino}-5-(propane thiouracil)-3H-[1,2,3]-triazophos[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethyl)cyclopentane-1,2- diol. Molecular formula: C23H28F2N6O4S, molecular weight: 522.57. [0006] The chemical formula of its optical isomer II is: (1S,2S,3R,5S)-3-[7-{[(1S,2S)-2-(3,4-difluorobenzene)cyclopropyl]amino} -5-(Propylthiouracil)-3H-[1,2,3]-triazophos[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethyl)cyclopentane -1,2-diol [0007...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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