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Method for measuring atosiban acetate related substance

A technology of atosiban acetate and related substances, which is applied in the field of chemical analysis, can solve problems such as allergic reactions, adverse reactions, and no analysis and identification methods, and achieve the effect of controlling related substances and improving safety

Inactive Publication Date: 2019-01-04
南京康舟医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Atosiban is prone to produce impurities during production and storage, and impurities are likely to cause allergic reactions, toxicity and other adverse reactions, but there is no method for analyzing and identifying impurities in atosiban acetate in the prior art

Method used

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  • Method for measuring atosiban acetate related substance
  • Method for measuring atosiban acetate related substance
  • Method for measuring atosiban acetate related substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The present embodiment provides a method for determining related substances of atosiban acetate, comprising the following steps:

[0049] Take atosiban acetate (the atosiban acetate after the strong degradation experiment has been carried out), add mixed solution to dissolve and dilute to make the solution containing atosiban acetate 1.0mg in every 1ml, as need testing solution; Precisely measure an appropriate amount of the test solution, dilute it with a mixed solution to make a solution containing 10 μg of atosiban acetate per 1 ml, as the sample injection solution. Inject the sample and record the chromatogram.

[0050] Take human insulin (molecular weight 5808) reference substance, thymosin α1 (molecular weight 3108) reference substance, somatostatin (molecular weight 1638) reference substance and atosiban acetate reference substance respectively, add mixed solution to dissolve and dilute to make each 1ml A solution containing 100 μg / ml of human insulin, thymosin ...

Embodiment 2-5

[0056] The method for determining related substances of atosiban acetate provided in Examples 2-5 is basically the same as that in Example 1, except that the operating conditions change.

Embodiment 2

[0057] Embodiment 2: chromatographic conditions: the mass percent of need testing solution is 1.5mg / ml, and the volume ratio of mobile phase A and mobile phase B is 80:20, and mobile phase A is the 1mol / ml phosphate solution that pH is 2.0, The mobile phase B is methanol, the flow rate is 1.1ml / min, the column temperature is 21-37°C; the detection wavelength is 225nm.

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Abstract

The invention relates to the field of the chemical analysis and in particular to a method for measuring an atosiban acetate related substance. The method for measuring the atosiban acetate related substance comprises the following steps: using globular protein hydrophilic modified silica gel as a chromatographic column filling and loading a sample of test solution, after eluting by using a mobilephase A of which solution is acidic and an organic solvent as a mobile phase B, detecting, wherein the eluting is performed in a volume proportion of the mobile phase A and the mobile phase B which is60-90:10-40. The method is capable of rapidly and effectively separating and detecting atosiban acetate crude drugs and the related substances in injection.

Description

technical field [0001] The invention relates to the field of chemical analysis, in particular to a method for determining related substances of atosiban acetate. Background technique [0002] Atosiban is currently the only uterine-specific tocolytic approved by the European Medicines Agency for the treatment of premature labor. Its mechanism of action is to compete with oxytocin for oxytocin receptors on the myometrium, decidua, and fetal membranes. , reducing the efficacy of oxytocin, reducing the level of calcium ions on muscle cells, thereby inhibiting uterine contractions. During the production and storage of atosiban, impurities are likely to be produced, and the impurities are likely to cause allergic reactions, toxicity and other adverse reactions, but there is no method for analyzing and identifying the impurities of atosiban acetate in the prior art. Contents of the invention [0003] The invention provides a method for determining related substances of atosiban ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 徐健峰张瑾苏晴业新龙王莉萍吴一飞
Owner 南京康舟医药科技有限公司
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