Detection method for related substances in ganirelix acetate injection

A technique for ganirelix and its detection method, which is applied in the field of detection of related substances in ganirelix acetate injection, and can solve problems such as affecting quantitative results, difficulty in accurate integration, poor separation of impurities, etc.

Pending Publication Date: 2021-04-30
南京诺卡医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] The relative retention time of some impurities close to the main peak in the existing analysis method for related substances of ganirelix acetate injection is very close. During the actual detection process, it was found that the resolution of these impurities

Method used

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  • Detection method for related substances in ganirelix acetate injection
  • Detection method for related substances in ganirelix acetate injection
  • Detection method for related substances in ganirelix acetate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Solvent Take 2.35g of mannitol, add 40ml of water to dissolve, add 10mg of glacial acetic acid, mix well, adjust the pH value to 4.9-5.1 with 1mol / L sodium hydroxide solution or 5% (v / v) acetic acid solution, and add water to 50ml.

[0036] Impurity stock solution Accurately weigh 5 mg of the above-mentioned known impurity reference substance into a 10 ml volumetric flask, dissolve with a solvent and dilute to a constant volume to make a solution containing about 0.5 mg / ml as the impurity stock solution.

[0037] System Suitability Solution Precisely weigh 12.5 mg of ganirelix acetate reference substance into a 25 ml volumetric flask, pipette 125 μl of each impurity stock solution into it, dilute with solvent to make ganirelix acetate containing about 0.5 mg, A solution of 2.5 μg of each impurity was used as a system suitability solution.

[0038] Chromatographic conditions:

[0039] Use octadecylsilane bonded silica gel as a filler (WELCH Ultimate LP-18 4.6×250mm, 3μm...

Embodiment 2

[0047] Solvent, impurity stock solution and system suitability solution are the same as in Example 1.

[0048] API stock solution:

[0049] Precisely weigh 5 mg of ganirelix acetate API (API) into a 10 ml volumetric flask, dissolve it with a solvent and dilute to a constant volume to make a solution containing about 0.5 mg / ml as the API stock solution.

[0050] Mixed impurity solution:

[0051] Precisely pipette 20 μl each of the impurity 5 and impurity 7 stock solutions, 60 μl each of the impurity 3 and impurity 6 impurity stock solutions, and 40 μl each of the remaining impurities and the API stock solution into a 100ml volumetric flask, dissolve and dilute to volume with a solvent, and shake well. .

[0052] Chromatographic conditions:

[0053] Use octadecylsilane bonded silica gel as a filler (WELCH Ultimate LP-18 4.6×250mm, 3μm or a chromatographic column with equivalent performance);

[0054] Detection wavelength 210nm;

[0055] Column temperature 50°C;

[0056] Mobi...

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Abstract

The invention discloses a detection method for related substances in a ganirelix acetate injection, which has the advantages of quickness, simplicity, convenience, high sensitivity, accuracy and reliability and is suitable for separating and determining the related substances in the ganirelix acetate injection. According to the method, the comprehensive influence of an analysis column, a mobile phase, a gradient elution program, a flow rate and a column temperature on separation and detection is comprehensively considered, so that the detection result is optimized, and the method has the advantages of rapidness, simplicity, convenience, high sensitivity, accuracy and reliability, and is suitable for separating and determining related substances of the ganirelix acetate injection.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting related substances in ganirelix acetate injection. Background technique [0002] The relative retention time of some impurities close to the main peak in the existing analysis method for related substances of ganirelix acetate injection is very close. During the actual detection process, it was found that the resolution of these impurities was very poor, and it was difficult to integrate accurately, which would affect the quantitative results. Therefore, Therefore, it is necessary to further develop a method that can effectively separate and quantitatively detect related substances in ganirelix acetate injection. [0003] In view of this, the present invention is proposed. Contents of the invention [0004] The object of the present invention is to provide a method for detecting related substances in ganirelix acetate injection in order to overcome...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 孙浩张瑾贺宜龙业新龙苏晴卜远芬徐健峰
Owner 南京诺卡医药技术有限公司
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