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Method for detecting ketotifen fumarate nasal drop content with UPLC (ultra-performance liquid chromatography)

A technology of ketotifen fumarate and ultra-high performance liquid phase, which is applied in the field of chemical detection, can solve problems such as poor specificity, and achieve the effects of avoiding interference of impurities and objective and inaccurate identification results.

Inactive Publication Date: 2016-06-15
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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Embodiment 1

[0015] A method for detecting the content of ketotifen fumarate nasal drops by ultra-high performance liquid chromatography, comprising the following steps successively:

[0016] Precisely get 1ml of ketotifen fumarate nasal drops sample solution and put it in a 100mL measuring bottle, add methanol to dilute to the mark, filter with a 0.22 micron filter membrane, get 2 μl and inject it into the ultra-high performance liquid chromatograph, the high performance liquid chromatograph described The chromatographic conditions described for the Shimadzu ultra-high performance liquid chromatograph NexeraUHPLCLC-30A are as follows:

[0017] The chromatographic column uses octadecylsilane bonded silica gel as filler, size 2.1mm×50mm, 1.7μm, water containing 0.5% formic acid as mobile phase A, acetonitrile as mobile phase B, according to the difference of A:B Gradient elution is carried out according to the ratio; the elution time is 18 minutes, and the detection wavelength of ultraviole...

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Abstract

The invention provides a method for detecting ketotifen fumarate nasal drop content with UPLC (ultra-performance liquid chromatography), and aims at providing a method for detecting ketotifen fumarate nasal drop content with UPLC, which is capable of preventing interferences from other impurities, efficient and time-saving, and objective in identification result. The method sequentially comprises the following steps: precisely taking 1ml of a ketotifen fumarate nasal drop sample solution, and placing the solution in a 1000ml measuring flask; adding methanol to dilute the solution to a scale; performing filtration by adopting a filtering membrane, and injecting 2 microliters of filtrate into an ultra-performance liquid chromatograph for detection. The method 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, a method for detecting the content of ketotifen fumarate nasal drops by ultra-high performance liquid chromatography; it belongs to the technical field of chemical detection. 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 avoiding other impurity interference, efficient time-saving, the method for ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
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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