Method for detecting related substances in terbutaline sulfate

A technology of terbutaline sulfate and related substances, applied in measuring devices, instruments, scientific instruments, etc., can solve the problem of no retention of strong polar impurities, incomplete elution of weak polar impurities, damage to chromatographic columns and instruments, etc. question

Active Publication Date: 2021-07-30
CHENGDU BRILLIANT PHARMA CO LTD +1
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0006] However, in the application process, it was found that the pharmacopoeia method has the following defects: the isocratic elution method makes strong polar impurities not retained, and weak polar impurities cannot be completely eluted
In order to take into account the polarity of each impurity, it is necessary to use a gradient elution method, and gradually increase the proportion of the organic phase during the elution process, but as the proportion of the organic phase increases, the high concentration of ammonium formate and sodium hexanesulfonate in the mobile phase will salt analysis, causing damage to the chromatographic column and instrument

Method used

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  • Method for detecting related substances in terbutaline sulfate
  • Method for detecting related substances in terbutaline sulfate
  • Method for detecting related substances in terbutaline sulfate

Examples

Experimental program
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Embodiment 1

[0043] Chromatographic conditions:

[0044] Chromatographic column: YMC Pack ODS-AQ, 4.6mm×250mm, 5μm

[0045] Mobile phase A: 0.05mol / L ammonium formate buffer solution (adjust the pH value to 3.0 with trifluoroacetic acid);

[0046] Mobile Phase B: Methanol

[0047] Flow rate: 1.0ml / min; Injection volume: 20μl; Column temperature: 40℃; Detection wavelength: 276nm;

[0048] Gradient elution program:

[0049]

[0050] Note: It is necessary to connect the ghost peak trapping column (Welch Ghost-Buster 4.6*50mm or ghost peak trapping column with equivalent performance) before the active valve

[0051] 1 System applicability inspection

[0052] Accurately weigh an appropriate amount of terbutaline sulfate and each impurity reference substance respectively, add diluent [methanol-water (20:80)] to dissolve and dilute to make magnesium 1ml containing terbutaline sulfate with a concentration of 1mg, TBS4-Z5, The mixed solutions with TBS3 concentrations of 1.5 μg were analyzed...

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Abstract

The invention provides a method for detecting related substances in terbutaline sulfate. According to the method, high performance liquid chromatography is adopted for detection. The method can effectively realizethe retention of the strong-polarity impurities and the effective elution of the weak-polarity impurities, and meanwhile, can reduce the damage of the solvent to a chromatographic facility.

Description

technical field [0001] The invention relates to a method for detecting related substances in terbutaline sulfate. Background technique [0002] Terbutaline sulfate, the chemical name is (±)-α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), the structural formula is as follows, it is an adrenergic Agonists can selectively stimulate β2-receptors, relax bronchial smooth muscle, inhibit the release of endogenous spasm-causing substances and edema caused by endogenous media, improve the clearance ability of bronchial mucosal ciliated epithelium, and relax uterine smooth muscle. It is mainly used for bronchial asthma, chronic bronchitis and other pulmonary diseases accompanied by bronchospasm. It can also be used to prevent premature birth and fetal asphyxia. It has the characteristics of high selectivity and few side effects, and has been widely used at home and abroad. This variety is currently recorded in China, the United States, Japan, Europe, and the Br...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/065
Inventor 葛志乐韩冰容鲁智婷陈翠翠罗鸣黄浩喜苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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