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Chromatographic analysis method for AHU377 and AHU377 isomers

A technology of AHU377, 1.AHU377, applied in the field of drug analysis, can solve the problems that have not yet been achieved, and achieve the effects of improving drug quality, controlling impurity content, and reducing potential risks

Active Publication Date: 2019-04-02
BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there are no national standards, national pharmacopoeias and literatures for chromatographic analysis of AHU377 and its isomers

Method used

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  • Chromatographic analysis method for AHU377 and AHU377 isomers
  • Chromatographic analysis method for AHU377 and AHU377 isomers
  • Chromatographic analysis method for AHU377 and AHU377 isomers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Testing conditions:

[0031] Instrument: Shimadzu 20A, Shimadzu 20AvT UV detector, detection wavelength: 254nm

[0032] Column: IC (3.5μm, 4.6×250mm) chiral column

[0033] Mobile phase: n-hexane-isopropanol-trifluoroacetic acid (90:10:0.1)

[0034] Diluent: n-hexane-isopropanol-trifluoroacetic acid (90:10:0.1)

[0035] Flow rate: 0.8mL / min

[0036] Column temperature: 40℃

[0037] Injection volume: 10μL

[0038] Detection steps:

[0039] Take 12.5mg each of AHU377 and AHU377-C mixture, AHU377-A and AHU377-B mixture, accurately weigh them, place them in a 50mL measuring flask, add mobile phase to dissolve and dilute to the mark, shake well, as a mixed stock solution. Take another 25 mg of the sample to be tested, accurately weigh it, and place it in a 50 mL measuring bottle. After adding an appropriate amount of mobile phase to dissolve, add 0.5 ml of the above-mentioned mixed stock solution, add mobile phase to dilute to the mark, and shake it as a system suitability solution.

[0...

Embodiment 2

[0042] Testing conditions:

[0043] Instrument: Shimadzu 20A, Shimadzu 20AvT UV detector, detection wavelength: 254nm

[0044] Column: IC (3.5μm, 4.6×250mm) chiral column

[0045] Mobile phase: n-hexane-isopropanol-trifluoroacetic acid (90:10:0.1)

[0046] Diluent: n-hexane-isopropanol-trifluoroacetic acid (90:10:0.1)

[0047] Flow rate: 0.8ml / min

[0048] Column temperature: 40℃

[0049] Injection volume: 10μL

[0050] Detection steps:

[0051] Take about 25mg of this product, accurately weigh it, put it in a 25ml measuring flask, add mobile phase to dissolve and dilute to the mark, shake it well, and use it as the test solution;

[0052] Precisely take 20μL of the test solution, and perform the detection and analysis according to the above detection conditions, see figure 2 . figure 2 The isomers AHU377-A, AHU377-B and AHU377-C were not detected in the test product. The optical purity of this product meets the quality requirements, and this method can be used for quality monitoring o...

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Abstract

The invention provides a chromatographic analysis method for AHU377 and AHU377 isomers. The method adopts high performance liquid chromatography, and uses a bonded chiral chromatographic column as a chromatographic column. Trifluoroacetic acid and other two organic solvents form a ternary mobile phase with a certain ratio, and the flow rate of mobile phase is 0.7-1.0 ml / min. The method can separate AHU377 and three isomers thereof under one condition simply and accurately.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical analysis, and specifically relates to a chromatographic analysis method of AHU377 and its isomers. Background technique [0002] AHU377, namely 4-(((2R,4S)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentane-2 -Yl)amino)-4-oxobutyric acid, which can be combined with angiotensin IIAT1 receptor antagonist valsartan in a molar ratio of 1:1 to form LCZ696, which belongs to angiotensin II (AT2) receptor and enkephalin The dual inhibitor of peptidase (Neprilysin) receptor has better antihypertensive effect than standard antihypertensive drugs. It is a new type of drug for the treatment of heart failure. [0003] The structural formula of AHU377 is as follows: [0004] [0005] AHU377 has two chiral centers, that is, three isomers: AHU377-A (configuration is RS), AHU377-B (configuration is RR) and AHU377-C (configuration is SS). [0006] At present, there is no chromatographic analysis method for AHU3...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 李利芳景元姚云凡刘昆高世静陶新华
Owner BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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