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High performance liquid chromatography analysis method for alvimopan or its related substances

A technology of high performance liquid chromatography and related substances, which is applied in the field of high performance liquid chromatography determination of alvimopan or its related substances, and can solve the problem of the absence of intermediates or its related substances and the method of determination of alvimopan, etc. problem, to achieve the effect of simple and fast method and improving work efficiency

Inactive Publication Date: 2016-12-21
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] So far, there is no literature report on the intermediates involved in the synthesis of alvimopan or its related substances and the method for the determination of alvimopan

Method used

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  • High performance liquid chromatography analysis method for alvimopan or its related substances
  • High performance liquid chromatography analysis method for alvimopan or its related substances
  • High performance liquid chromatography analysis method for alvimopan or its related substances

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0084] 1) Preparation of reference solution

[0085] Select the described alvimopan or related substances of alvimopan as the reference substance, dissolve it with a diluent, and prepare a solution containing 1-100 μg of the described alvimopan or related substances of alvimopan per 1 ml as a reference substance. Reference substance solution, wherein said diluent is the mixed solution of phosphate buffer solution-organic phase or the mixed solution of acetate buffer solution-organic phase;

[0086] 2) Preparation of the test solution

[0087] Get the described mixture that contains Alvimopan and / or Alvimopan related substance, adopt diluent to dissolve, be mixed with the solution that every 1ml contains the described mixture of 0.1-1mg as need testing solution, wherein said The diluent is the mixed solution of phosphate buffer solution-organic phase or the mixed solution of acetate buffer solution-organic phase;

[0088] 3) Chromatographic conditions

[0089] High-efficienc...

Embodiment 1

[0167] Equipment: HPLC: Agilent 1100, DAD (or VWD) detector, Agilent 1100 chromatographic workstation; chromatographic column: kromasil C18, 250×4.6mm, 5μm.

[0168] Chromatographic conditions: mobile phase: mobile phase A: 0.01mol / L sodium dihydrogen phosphate solution (adjust the pH to 2.5 with phosphoric acid); mobile phase B: acetonitrile, using gradient elution. Detection wavelength: 210nm; column temperature: 30°C; flow rate: 1ml / min; injection volume: 10μl.

[0169] Diluent: 0.01mol / L sodium dihydrogen phosphate solution (adjust pH to 2.5 with phosphoric acid): acetonitrile = 83:17.

[0170] The specific gradient elution procedure is as follows:

[0171] time (min)

Mobile phase A(%)

Mobile phase B(%)

0

83

17

10

83

17

60

50

50

80

50

50

80.1

83

17

90

83

17

[0172] Experimental method: Mix impurities A, B, C, D, E, F, benzyl bromide, methyl acrylate and alvimopan, dissolve them...

Embodiment 2

[0175] Instruments and equipment: high performance liquid chromatography: Agilent 1100, DAD (or VWD) detector, Agilent 1100 chromatographic workstation; chromatographic column: kromasil C8, 250×4.6mm, 5μm.

[0176] Chromatographic conditions: mobile phase: mobile phase A: 0.01mol / L ammonium acetate solution (adjust pH 5.0 with acetic acid); mobile phase B: methanol, using gradient elution. Detection wavelength: 210nm; column temperature: 20°C; flow rate: 0.6ml / min; injection volume: 10μl.

[0177] Diluent: 0.01mol / L sodium dihydrogen phosphate solution (adjust pH to 2.5 with phosphoric acid): acetonitrile = 83:17.

[0178] The specific gradient elution procedure is as follows:

[0179] time (min)

Mobile phase A(%)

Mobile phase B(%)

0

70

30

15

70

17

70

30

70

110

30

70

[0180] Experimental method: Mix impurities A, B, C, D, E, F, benzyl bromide, methyl acrylate and alvimopan, dissolve them in a diluent, and...

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Abstract

The invention provides a high-performance liquid chromatography analysis method for alvimopan or its related substances. The method of the present invention is a method for component analysis of a mixture containing alvimopan and / or related substances of alvimopan by high performance liquid chromatography. Compared with the prior art, the method of the present invention has the following advantages and positive effects: the method is simple and fast, can effectively detect each known related substance, and can accurately detect the content of the known related substance according to its response factor , can comprehensively control related substances in alvimopan and its preparations, improve drug safety, and provide a basis for formulating quality standards for alvimopan raw materials and preparations.

Description

technical field [0001] The invention relates to a high-performance liquid chromatography analysis method, in particular to a high-performance liquid chromatography determination method of alvimopan or its related substances. Background technique [0002] Alvimopan (Alvimopan, also known as Avimopan), chemical name: 2-([(2S)-2-([(3R,4R)-4-(3-hydroxyphenyl)-3,4- Dimethylpiperidin-1-yl] methyl)-3-phenylpropionyl] amino) acetic acid dihydrate, the chemical structural formula is as shown in formula I below: [0003] [0004] Formula I [0005] As a new peripheral μ-type opioid receptor antagonist, Alvimopan is clinically used for gastrointestinal dysfunction caused by surgery and the use of opioids, idiopathic constipation and irritable bowel syndrome. The commonly used synthetic route of Alvimopan is as follows: [0006] [0007] The above synthetic route can be specifically referred to the following documents: "Prather, D.E.; Werner, J.A.; Wad, J.A.; Frank, S.A. (Eli L...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/89
Inventor 易崇勤冯德春谢小飞苏强郭欲晓郑少辉
Owner NEW FOUNDER HLDG DEV LLC
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