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Method for rapidly measuring content of ketotifen fumarate in ketotifen fumarate naristillae

A technology of ketotifen fumarate and nasal drops, which is applied in the field of chemical detection, can solve the problems of poor specificity, and achieve the effects of high detection sensitivity, good product quality control, and good accuracy and repeatability

Inactive Publication Date: 2016-09-21
WUZHOU INST FOR FOOD & DRUG CONTROL
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Problems solved by technology

Its content determination method is ultraviolet spectrophotometry, which has poor specificity

Method used

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Effect test

Embodiment 1

[0017] A method for rapidly detecting ketotifen fumarate content in ketotifen fumarate nasal drops, comprising the steps in turn:

[0018] Precisely get 1ml of ketotifen fumarate nasal drops sample solution and put it in a 100mL measuring bottle, add acetonitrile to dilute to the mark, filter with a 0.22um filter membrane, get 2 μl and inject it into a liquid chromatograph, and the liquid chromatograph is Thermo double ternary liquid phase;

[0019] Described chromatographic conditions are as follows:

[0020] The parameters set during the analysis by liquid chromatography are as follows:

[0021] Chromatographic column: Thermo Syncronis Dim.mmAQ 1.7μm 50×2.1mm

[0022] Column temperature: 30°C

[0023] Flow rate: 0.8mL / min

[0024] The volume ratio of methanol-water-acetonitrile in the mobile phase is 30:40:30

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Abstract

The invention provides a method for rapidly measuring content of ketotifen fumarate in ketotifen fumarate naristillae, and aims at providing the method which is high-efficiency and time-saving and has good repeatability and high detection sensitivity for measuring content of ketotifen fumarate in ketotifen fumarate naristillae. The method includes the following steps in order: taking 1ml sample solution of ketotifen fumarate naristillae accurately, putting the sample solution into a 100ml measuring flask, adding acetonitrile to dilute to the scale, filtering the solution with a 0.22 micron filter membrane, and injecting 2 mul solution to the liquid chromatography. The chromatographic conditions are as follow: chromatographic column is Thermo Syncronis Dim. mmAQ1.7 mum 50*2.1 mm; column temperature is 30 DEG C; flow velocity is 0.8 ml / min; volume ratio of methyl alcohol-water-acetonitrile in the mobile phase is 30:40:30; and measurement wavelength is 287nm. The invention belongs to the technical field of chemical detection.

Description

technical field [0001] The invention provides a method for detecting the content of ketotifen fumarate nasal drops, specifically, an ultra-fast method for detecting the content of ketotifen fumarate in ketotifen fumarate nasal drops; it belongs to the chemical detection technology field. Background technique [0002] Ketotifen Fumarate Nasal Drops is an antihistamine and antiasthma drug, which has both histamine H1 receptor antagonism and inhibition of the release of allergic reaction mediators. It is mainly used for the treatment of allergic rhinitis, and it is an over-the-counter medicine for otolaryngology. "Chinese Pharmacopoeia" 2010 edition two collection. Its content determination method is ultraviolet spectrophotometry, which has poor specificity. Contents of the invention [0003] For above-mentioned deficiency, the object of the present invention is to provide a kind of efficient time-saving, good repeatability, the method for the detection ketotifen fumarate ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/027
Inventor 陈学松陈江涛廖强梁慧敏李亚李澄
Owner WUZHOU INST FOR FOOD & DRUG CONTROL
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