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Detection method for impurities G in ipratropium bromide aerosol

A technology of ipratropium bromide and a detection method is applied in the field of detection of impurity G in ipratropium bromide aerosol, and can solve the problems such as that the quality of ipratropium bromide aerosol cannot be fully controlled.

Active Publication Date: 2019-10-22
SICHUAN PURITY PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the pharmaceutical industry has long lacked an accurate and effective quantitative detection method for impurity G, so that the quality of ipratropium bromide aerosol cannot be fully controlled

Method used

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  • Detection method for impurities G in ipratropium bromide aerosol
  • Detection method for impurities G in ipratropium bromide aerosol
  • Detection method for impurities G in ipratropium bromide aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Use liquid chromatography to detect the mixed reference solution of impurities, and the chromatographic conditions are as shown in Table 1 and Table 2:

[0059] Table 1

[0060]

[0061]

[0062] Table 2 Gradient elution program

[0063] time (min) Mobile phase A% Mobile phase B% 0 80 20 32 80 20 63 40 60 68 80 20 75 80 20

[0064] Chromatograms such as figure 1 As shown, under this condition, both ipratropium bromide and impurity G can be detected, and the resolution is significantly greater than 1.5.

[0065] An additional problem is that there may be more than ten kinds of impurities in ipratropium bromide aerosol, and conventional detection methods cannot realize the simultaneous separation and detection of impurity G and other impurities. And in the present invention, further research verification test confirms, the detection method provided by the present invention can realize the synchronous separation and ...

Embodiment 2

[0067] Further optimize the concentration of buffer salts and ion-pairing reagents to reduce their damage to the chromatographic column and prolong the service life of the chromatographic column. Detect the impurity mixed control solution according to the chromatographic conditions of the following table 4:

[0068] table 3

[0069]

[0070] The gradient elution procedure is the same as in Example 1.

[0071] Chromatograms such as figure 2 Shown, under this condition, still can realize the detection of impurity G and ipratropium bromide, and have better resolution.

[0072] Like the further study of Example 1, the optimization scheme of Example 2 also further considered its detection effect on simultaneous detection of multiple impurities. Further verification experiments confirmed that the optimization scheme in Example 2 can still maintain the simultaneous separation and detection of impurity G and various ipratropium bromide aerosols while reducing the damage to the ...

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Abstract

The present invention discloses a detection method for impurities G in ipratropium bromide aerosol. According to the detection method, double flow phases and more than three sections of gradient elution programs are adopted; and a liquid phase chromatography method is adopted to measure the content of the impurities G in the ipratropium bromide aerosol. With the detection method of the invention adopted, an accurate and efficient solution can be provided for the defect that effective detection means are not available for the detection of impurities G in the field.

Description

technical field [0001] The invention belongs to the technical field of drug quality control, in particular to a detection method for impurity G in ipratropium bromide aerosol. Background technique [0002] Ipratropium bromide, molecular formula: C 20 h 30 BrNO 3 , molecular weight 412.4, CAS number: 22254-24-6, used in medicine as its monohydrate. Ipratropium bromide aerosol, developed by Boehringer Ingelheim Pharmaceutical Company of Germany, is mainly used to relieve bronchospasm and wheezing symptoms caused by chronic obstructive pulmonary disease; chronic obstructive bronchitis with or without emphysema; mild to moderate bronchial asthma. [0003] The ipratropium bromide aerosol is prepared from the crude drug ipratropium bromide as an active ingredient through a preparation process. Compared with raw materials, ipratropium bromide aerosol has additional auxiliary materials such as citric acid, ethanol, water, etc., and is packaged with specific packaging materials,...

Claims

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Application Information

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IPC IPC(8): G01N30/34G01N30/02
CPCG01N30/34G01N30/02
Inventor 韩佳朱柯武李丛菊贺钢民杨丽吴林侯曙光吴君赵聪燕
Owner SICHUAN PURITY PHARM CO LTD
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