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Method for detecting impurities in cetrorelix acetate polymer

A technology of cetrelix acetate and detection method, applied in the field of drug analysis, can solve the problem that size exclusion chromatography is difficult to quantify accurately, and achieves molecular weight linear relationship and good durability, stable baseline and good method specificity Effect

Active Publication Date: 2022-06-14
南京瑞克卫生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, in the quality control of the raw materials and preparations of cetrorelix acetate, the relative molecular weights of the reported impurities and the relative molecular weights of cetrorelix acetate are all within 10%. hard to quantify

Method used

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  • Method for detecting impurities in cetrorelix acetate polymer
  • Method for detecting impurities in cetrorelix acetate polymer
  • Method for detecting impurities in cetrorelix acetate polymer

Examples

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Embodiment 1

[0054] Example 1: System suitability, precision and specificity

[0055] The present embodiment provides a method for detecting the impurities of a cetrorelix acetate polymer, and the specific steps are as follows:

[0056] (1) Chromatographic condition settings:

[0057] Chromatographic column: TSK GEL 2000SWXl column, 7.8mm×300mm, 5µm

[0058] Column temperature: 30℃

[0059] Mobile phase: acetonitrile-water-trifluoroacetic acid (40:60:0.05)

[0060] Flow rate: 0.7ml / min

[0061] Detection wavelength: 210nm

[0062] Injection volume: 20μl

[0063] Running time: 30min

[0064] (2) Solvent preparation: prepare a solution of acetonitrile-water-trifluoroacetic acid (volume ratio of 40:60:0.05) as solvent;

[0065] (3) Preparation of system adaptability solution: respectively take aprotinin reference substance, thymus method new reference substance, eptifibatide reference substance, reduced glutathione reference substance, and cetrorelix acetate reference substance, and ad...

Embodiment 2

[0090] This embodiment provides a method for detecting impurities in a polymer of cetrorelix acetate. The only difference from Example 1 is that the concentration of cetrorelix acetate in the test solution is 0.5 mg / mL; the system The mass concentrations of aprotinin, thymosin, eptifibatide, reduced glutathione, and cetrorelix acetate in the adaptive solution were 0.5 mg / mL. The detection method adopts the self-control method to carry out quantitative analysis, and the content of polymer impurities is calculated to be 0.03%.

Embodiment 3

[0092] The present embodiment provides a method for detecting impurities in a polymer of cetrorelix acetate. The only difference from Example 1 is that the concentration of cetrorelix acetate in the test solution is 0.1 mg / mL; the system The mass concentrations of aprotinin, thymosin, eptifibatide, reduced glutathione, and cetrorelix acetate in the adaptive solution were 0.1 mg / mL. The detection method adopts the self-control method to carry out quantitative analysis, and the content of polymer impurities is calculated to be 0.04%.

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Abstract

The invention provides a detection method of cetrorelix acetate polymer impurities. According to the method, cetrorelix peaks and polymer impurity peaks thereof are effectively separated by adopting a molecular exclusion color vapor overflow method and strictly controlling the proportion of mobile phase components and setting reasonable elution conditions, the separation effect is outstanding, a base line is stable, the stability is good, the specificity is good, the sensitivity is high, various polymer impurities can be detected at the same time, the separation degree of each polymer impurity is good, and the accuracy is high. And the method can eliminate the interference of small molecular impurities in the cetrorelix acetate bulk drug or the preparation thereof, can be applied to the quality control of cetrorelix acetate, and has great positive progress effect and practical application value.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting impurities in a cetrorelix acetate polymer. Background technique [0002] Gonadotropin-releasing hormone (GnRH) is secreted by the hypothalamus and binds to the pituitary GnRH receptor, causing the release of pituitary gonadotropins, namely luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in the secretion of estrogen, Sex steroid hormones such as testosterone. Cetrorelix is ​​a gonadotropin-releasing hormone (GnRH) antagonist, this drug works by inhibiting the action of GnRH, preventing the release of follicles before they are fully developed, and also stimulates the ovaries to produce more eggs for female fertility treat. [0003] Cetrorelix acetate is a chemically synthesized decapeptide, its chemical name is: N-acetyl-3-(2-naphthalene)-d-alanyl-p-chloro-d-phenylalanyl-3-(3 -pyridyl)-d-alanyl-l-seryl-l-tyrosyl-N5-carbamo...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/32G01N30/34G01N30/60
CPCG01N30/02G01N30/06G01N30/32G01N30/34G01N30/6052G01N2030/324
Inventor 胡长鸣张雅然白晓雪
Owner 南京瑞克卫生物医药有限公司
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