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Method for detecting terbutaline sulfate injection and related substances

A technology for detecting terbutaline sulfate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not providing terbutaline sulfate injection and detection methods for degraded impurities, and achieve good durability and improved The effect of high control and impurity separation

Active Publication Date: 2022-06-28
广东金城金素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] As can be seen from Table 1, in existing CP, EP, USP methods, do not provide a kind of simultaneous detection terbutaline sulfate injection and degradation impurity B , C, F detection method, in order to better quality control terbutaline sulfate injection, this is an unresolved technical problem for those skilled in the art

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  • Method for detecting terbutaline sulfate injection and related substances
  • Method for detecting terbutaline sulfate injection and related substances
  • Method for detecting terbutaline sulfate injection and related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] System suitability test for the detection of terbutaline sulfate injection and related substances by high performance liquid chromatography, the test conditions are:

[0067] Chromatographic column: Agilent ZORBAX Eclipse Plμs-C18 (250×4.6mm, 5μm);

[0068] Mobile phase: take 4.08g of sodium hexanesulfonate, 1.41g of sodium sulfate and 3.15g of ammonium formate, put it in a 1000mL measuring flask, add about 960mL of water, add formic acid (about 8mL) to adjust the pH value to 3.0, dilute to the mark with water, shake It is mobile phase A until it is completely dissolved. Take 800 mL of mobile phase A and 200 mL of methanol (mobile phase B), and mix well;

[0069] Detection wavelength: 276nm;

[0070] Column temperature: 30℃;

[0071] Flow rate: 1.0mL / min;

[0072] Injection volume: 50 μL;

[0073] System suitability solution: take appropriate amount of terbutaline sulfate standard and impurity B, C, F reference substances, add mobile phase to dissolve and quantitat...

Embodiment 2

[0079] The detection conditions of Terbutaline Sulfate Injection and related substances are as follows:

[0080] Chromatographic column: Agilent ZORBAX Eclipse Plμs-C18 (250×4.6mm, 5μm);

[0081] Mobile phase: take 4.08g of sodium hexanesulfonate, 1.41g of sodium sulfate and 3.15g of ammonium formate, put it in a 1000mL measuring flask, add about 960mL of water, add formic acid (about 8mL) to adjust the pH value to 3.0, dilute to the mark with water, shake It is mobile phase A until it is completely dissolved. Take 800 mL of mobile phase A and 200 mL of methanol (mobile phase B), and mix well;

[0082] Detection wavelength: 276nm;

[0083] Column temperature: 30℃;

[0084] Flow rate: 1.0mL / min;

[0085] Injection volume: 50 μL;

[0086] Test solution: Take 5 tubes of homemade Terbutaline Sulfate Injection, mix well, take an appropriate amount, and use it as the test solution (0.5mg / mL);

[0087] Wherein, the preparation method of self-made terbutaline sulfate injection: ...

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Abstract

The invention relates to the technical field of drug detection methods, in particular to a detection method for determining terbutaline sulfate injection and related substances, the detection method adopts high performance liquid chromatography for detection, and the detection conditions are as follows: a mobile phase is composed of a mobile phase A and a mobile phase B, wherein the mobile phase A is an ammonium formate-formic acid buffer solution containing 3.75-4.31 g / L of sodium hexanesulfonate and 1.25-1.57 g / L of sodium sulfate, and the pH value is 3.0 + / -0.1; the mobile phase B is methanol; the mixing volume ratio of the mobile phase A to the mobile phase B is 80: 20; the detection method can realize simultaneous detection of degradation impurities of raw material medicines and preparations, and has the advantages of high separation degree, good durability and the like.

Description

technical field [0001] The invention relates to the technical field of drug detection methods, in particular to a detection method for terbutaline sulfate injection and related substances. Background technique [0002] Terbutaline sulfate, English name Terbutaline Sulfate, chemical name is (±)α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), the structural formula is as follows: [0003] [0004] Terbutaline sulfate is an adrenergic agonist that selectively activates β2 receptors, relaxes bronchial smooth muscle, inhibits the release of endogenous spasmodic substances and edema caused by endogenous mediators, and improves bronchial mucociliary epithelial clearance It can also relax uterine smooth muscle. It is mainly used to treat bronchial asthma, chronic bronchitis and other lung diseases with bronchospasm. It can also be used to prevent premature birth and fetal asphyxia. It has the characteristics of high selectivity and few side effects. [0005...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/065Y02A50/30
Inventor 周白水赵晓宝蒲昊昊
Owner 广东金城金素制药有限公司
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