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An analytical method for separating and detecting tenofovir alafenamide fumarate isomers

A technology of propofol fumarate and tenofovir, which is applied in the field of medical analysis and detection, and achieves the effects of simple separation method and accurate results

Active Publication Date: 2022-06-17
济南新科医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The above method can effectively separate and detect tenofovir alafenamide fumarate and one of its diastereoisomers, but it cannot effectively separate and detect other diastereoisomers at the same time, as well as other existing relative substance

Method used

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  • An analytical method for separating and detecting tenofovir alafenamide fumarate isomers
  • An analytical method for separating and detecting tenofovir alafenamide fumarate isomers
  • An analytical method for separating and detecting tenofovir alafenamide fumarate isomers

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Embodiment 1

[0028] The analytical method for separation and detection of tenofovir alafenamide fumarate isomers of the present invention comprises:

[0029] 1) Chromatographic column: Daicel bonded chiral column;

[0030] 2) Mobile phase: a mixed solution of one or more of n-hexane, isopropanol, methanol, ethanol, methyl tert-butyl ether, tetrahydrofuran, dichloromethane, chloroform, ethyl acetate and acetonitrile; Good chiral separation effect, suitable additives such as diethylamine, ethylenediamine, etc. can be added to the mobile phase;

[0031] 3) Detection wavelength: 260nm;

[0032] 4) Column temperature: 27~45℃;

[0033] 5) Flow rate: 0.7mL / min~1.5mL / min;

[0034] 6) Isomer mixed stock solution: take about 5mg of each isomer, put it in a 10ml measuring flask, dissolve it with absolute ethanol and dilute to the mark as the isomer mixed stock solution;

[0035] 7) System suitability solution: take about 30-70 mg of tenofovir fumarate and tenofovir alafenamide sample, accurately ...

Embodiment 2

[0048] The analytical method for separation and detection of tenofovir alafenamide fumarate isomers of the present invention comprises:

[0049] 1) Chromatographic column: CHIRALPAK IC (4.6mm×250mm, 5μm);

[0050] 2) Mobile phase: n-hexane: isopropanol: methanol = 85:7:8;

[0051] 3) Detection wavelength: 260nm;

[0052] 4) Column temperature: 30℃;

[0053] 5) Flow rate: 1.0mL / min;

[0054] 6) Injection volume: 10µL;

[0055] 7) Isomer mixed stock solution: take about 5mg of each isomer, put it in a 10ml measuring bottle, dissolve it with absolute ethanol and dilute it to the mark, as the isomer mixed stock solution;

[0056] 8) System suitability solution: take about 50 mg of tenofovir fumarate and tenofovir alafenamide sample, accurately weigh it, put it in a 100 ml volumetric flask, add 1 ml of isomer mixed stock solution, dissolve it with absolute ethanol and dilute to the mark, as a system suitability solution.

[0057] Take 10ul of the system suitability solution, ...

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Abstract

The invention discloses an analysis method for separating and detecting the isomers of tenofovir alafenamide fumarate, which adopts a Daicel bonded chiral chromatographic column and uses a mixed solution of n-hexane, isopropanol and methanol as the mobile phase. Perform isocratic elution under certain conditions; the present invention separates and detects the analytical method of tenofovir alafenamide fumarate isomers, the method is simple, and can simultaneously separate and detect multiple isomers of tenofovir alafenamide fumarate and other related substances, and the chromatographic peak shape is good, the result is accurate, and can be used for the quality control of the tenofovir alafenamide fumarate production process.

Description

technical field [0001] The invention relates to an analysis method for separating and detecting tenofovir alafenamide fumarate isomers, belonging to the field of medical analysis and detection. Background technique [0002] Tenofovir alafenamide fumarate, its structural formula is figure 1 As shown, tenofovir fumarate, the English name is Tenofovir Alafenamide, is a prodrug of tenofovir against HIV and hepatitis B virus (code GS-7340) launched by Gilead. Tenofovir alafenamide fumarate is a compound containing 3 chiral centers, such as figure 2 As shown, it should theoretically have 7 optical isomers (including 3 pairs of diastereomers and 1 enantiomer), all of which are impurities. In the field of medicine, the control of impurities in chemicals is related to the quality and safety of medicines. Therefore, it is very meaningful to accurately analyze and detect related substances of chemicals and control their content. [0003] Chinese Patent Application No. 01813161.1 Nu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 葛国才王辉
Owner 济南新科医药科技有限公司