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Analysis method of elagolix sodium raw material and synthetic intermediate thereof

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., and achieve accurate confirmation The effect of reaction endpoint, reducing detection cost and ensuring quality controllability

Active Publication Date: 2019-11-26
江苏海岸药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • Analysis method of elagolix sodium raw material and synthetic intermediate thereof
  • Analysis method of elagolix sodium raw material and synthetic intermediate thereof
  • Analysis method of elagolix sodium raw material and synthetic intermediate thereof

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: 10uL;

[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 10uL of the above solution into the high performance liquid chromatograph, record the chromatogram, the result is as follows figure 1 .

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

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: 10uL;

[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 10uL of the above solution into the high performance liquid chromatograph, record the chromatogram, the result is as follows figure 2 .

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

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: 10uL;

[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 10uL of the above solution into the high performance liquid chromatograph, record the chromatogram, the result is as follows image 3 .

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

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Abstract

The invention discloses an analysis method of an elagolix sodium raw material and a synthetic intermediate thereof. The analysis method is characterized in that the elagolix sodium raw material and the synthetic intermediate thereof are analyzed by using high performance liquid chromatography. The test solution is a mixed solution of elagolix sodium, starting materials SM1, SM2, SM3 and SM4 and intermediates M1, M2 and M3, wherein the concentration of elagolix sodium is 0.5-1.5 mg / mL, the concentration of each starting material is 0.05-0.15 mg / mL, and the concentration of each intermediate is0.05-0.15 mg / mL. The method comprises the steps of selecting a Kromasil-Eternity-5-C18 chromatographic column, and taking a phosphate buffer solution and acetonitrile as mobile phases, wherein the volume ratio of the phosphate buffer solution to the acetonitrile is (90-95): (5-10); limiting the flow speed within the range of 0.9-1.0 ml / min, selecting a () detector with the detection wavelength of200-230nm, and analyzing the elagolix sodium raw material and the synthetic intermediate thereof. The method solves the problem of separation and detection of the elagolix sodium raw material and thesynthetic intermediate thereof, thereby ensuring the quality controllability of the elagolix sodium raw material or preparation thereof.

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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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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