A kind of analysis method of elagolix sodium raw material and its synthetic intermediate

A technology for analysis of elagolix sodium and its analysis method, which is applied in the field of analysis of elagolix sodium raw materials and its synthetic intermediates, can solve the problems of lack of reference analysis standards, obstacles to product application and promotion, etc., to ensure quality Controllability, reduce detection cost, improve the effect of response and symmetry

Active Publication Date: 2021-12-17
江苏海岸药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This makes the product have no reference analysis standard at this stage, which hinders the application and promotion of the product

Method used

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  • A kind of analysis method of elagolix sodium raw material and its synthetic intermediate
  • A kind of analysis method of elagolix sodium raw material and its synthetic intermediate
  • A kind of analysis method of elagolix sodium raw material and its synthetic intermediate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] 1. Instruments and conditions:

[0047] High performance liquid chromatography: Agilent 1260Ⅱ;

[0048] Chromatographic column: Kromasil-Eternity-5-C18 250*4.6mm;

[0049] Mobile phase A: 0.01mol / L potassium dihydrogen phosphate solution (containing 0.05% triethylamine, adjusted to pH=6.0 with phosphoric acid);

[0050] Mobile phase B: acetonitrile;

[0051] Mobile phase A: mobile phase B=95:5 (v:v);

[0052] Flow rate: 1.0mL / min;

[0053] Column temperature: 30°C;

[0054] Detection wavelength: 210nm;

[0055] Injection volume: 10μL;

[0056] 2. Implementation steps:

[0057] Weigh 100 mg of elagolix sodium, 10 mg of each intermediate and starting material, respectively, and place in a 100 mL measuring bottle, dissolve and constant volume, as the test solution. Inject 10 μL of the above solution into a high-performance liquid chromatograph, record the chromatogram, and the results are as follows: figure 1 .

[0058] Depend on figure 1 It can be seen that the r...

Embodiment 2

[0060] 1. Instruments and conditions:

[0061] High performance liquid chromatography: Agilent 1260Ⅱ;

[0062] Chromatographic column: Kromasil-Eternity-5-C18 250*4.6mm;

[0063] Mobile phase A: 0.02mol / L potassium dihydrogen phosphate solution (containing 0.05% triethylamine, adjusted to pH=6.0 with phosphoric acid);

[0064] Mobile phase B: acetonitrile;

[0065] Mobile phase A: mobile phase B=95:5 (v:v);

[0066] Flow rate: 1.0mL / min;

[0067] Column temperature: 30°C;

[0068] Detection wavelength: 210nm;

[0069] Injection volume: 10μL;

[0070] 2. Implementation steps:

[0071] Weigh 100 mg of elagolix sodium, 10 mg of each intermediate and starting material, respectively, and place in a 100 mL measuring bottle, dissolve and constant volume, as the test solution. Inject 10 μL of the above solution into a high-performance liquid chromatograph, record the chromatogram, and the results are as follows: figure 2 .

[0072] Depend on figure 2 It can be seen that t...

Embodiment 3

[0074] 1. Instruments and conditions:

[0075] High performance liquid chromatography: Agilent 1260Ⅱ;

[0076] Chromatographic column: Kromasil-Eternity-5-C18 250*4.6mm;

[0077] Mobile phase A: 0.01mol / L potassium dihydrogen phosphate solution (containing 0.05% triethylamine, adjusted to pH=6.0 with phosphoric acid);

[0078] Mobile phase B: acetonitrile;

[0079] Mobile phase A: mobile phase B=95:5 (v:v);

[0080] Flow rate: 1.0mL / min;

[0081] Column temperature: 40°C;

[0082] Detection wavelength: 210nm;

[0083] Injection volume: 10μL;

[0084] 2. Implementation steps:

[0085] Weigh 100 mg of elagolix sodium, 10 mg of each intermediate and starting material, respectively, and place in a 100 mL measuring bottle, dissolve and constant volume, as the test solution. Inject 10 μL of the above solution into a high-performance liquid chromatograph, record the chromatogram, and the results are as follows: image 3 .

[0086] Depend on image 3 It can be seen that the...

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Abstract

The invention discloses a method for analyzing the raw material of elagolix sodium and its synthetic intermediate, which is characterized in that the raw material of elagolix sodium and its synthetic intermediate are analyzed by high-performance liquid chromatography. Need testing solution is elagolix sodium, the mixed solution of starting material SM1, SM2, SM3, SM4 and intermediate M1, M2, M3; Select Kromasil-Eternity-5-C18 chromatographic column, with phosphate buffer solution and Acetonitrile was used as the mobile phase, and an ultraviolet detector was selected with a detection wavelength of 200-230nm to analyze the raw material of elagolix sodium and the synthetic intermediate. It solves the problem of separation and detection of elagolix sodium and its synthetic intermediates, and ensures the quality controllability of elagolix sodium raw materials or preparations.

Description

technical field [0001] The invention relates to an analysis method, in particular to an analysis method of elagolix sodium raw material and its synthetic intermediate. Background technique [0002] Elagolix is ​​an oral GnRH antagonist jointly developed by Abbvie and its partner Neurocrine Biosciences. It inhibits the pituitary gonadotropin-releasing hormone receptor and ultimately reduces the level of circulating gonadotropin. Currently, AbbVie is investigating elagolix for the treatment of some diseases mediated by gonadal hormones, such as uterine fibroids and endometriosis. So far, there have been more than 40 clinical trials of elagolix, involving a total of more than 3,000 patients. In addition, elagolix was launched in the United States on July 23, 2018, and its phase III clinical trial for the treatment of uterine fibroids is also underway, with great market prospects. [0003] Elagolix sodium is the raw material for producing Elagolix, and the molecular formula of...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/28
CPCG01N30/28G01N2030/067
Inventor 孙湛翔李洋
Owner 江苏海岸药业有限公司
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