Detection method for naphazoline hydrochloride and related substances thereof

A technology for naphazoline hydrochloride and related substances, which is applied in the detection field of naphazoline hydrochloride and related substances, and can solve the problems of low detection sensitivity, inability to quantitatively measure impurities, thin-layer chromatography is not as good as high-performance liquid chromatography, etc. problems, to achieve the effect of high sensitivity, good peak shape and strong specificity

Inactive Publication Date: 2017-11-24
山东绅联药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The main problem of this technical solution is that the related substance method is thin-layer chromatography (TLC method). In the inspection of related substances, various impurities cannot be quantitatively determined, and the detection sensitivity is low, so TLC is not as good as high-performance liquid chromatography.

Method used

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  • Detection method for naphazoline hydrochloride and related substances thereof
  • Detection method for naphazoline hydrochloride and related substances thereof
  • Detection method for naphazoline hydrochloride and related substances thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] (1) Detection conditions

[0039] Instrument: waters e2695 high performance liquid chromatography, 2998PDA detector, detection wavelength: 280nm;

[0040] Chromatographic column: waters XBridge C18 (250mm×4.6mm, 5μm) chromatographic column;

[0041] Solvent: mobile phase A: sodium octane sulfonate solution (take 1.57g sodium octane sulfonate and 1.7g potassium dihydrogen phosphate, dissolve and dilute to 1000ml with water, add 5ml triethylamine, adjust the pH value to 2.8 with phosphoric acid) ; Mobile phase B: acetonitrile; Mobile phase A and mobile phase B volume ratio is: 80:20;

[0042] Flow rate: 1.0mL / min

[0043] Column temperature: 30°C;

[0044] Injection volume: 20μL;

[0045] Carry out linear gradient elution according to Table 1.

[0046] Table 1

[0047]

[0048] (2) Detection steps

[0049] Preparation of the mixed reference substance solution: take respective appropriate amounts of naphazoline hydrochloride reference substance, impurity A, impur...

Embodiment 2

[0052] According to the similar detection method of Example 1, wherein, the sodium octane sulfonate solution concentration is replaced by 1.41g / L. The spectrum of its mixed reference substance is shown in Figure 4 , The chromatogram of the test product is shown in Figure 5 .

Embodiment 3

[0054] According to the similar detection method of Example 1, wherein, the sodium octane sulfonate solution concentration is replaced by 1.73g / L. The chromatogram of its mixed reference substance is shown in Figure 6 , The chromatogram of the test product is shown in Figure 7 .

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Abstract

The invention relates to the technical field of chemical drug analysis methods, and particularly relates to a detection method for naphazoline hydrochloride and related substances thereof. The method is characterized by comprising the steps of carrying out gradient elution on a high-performance liquid chromatograph, wherein the chromatographic conditions are as follows: a chromatographic column is an octadecylsilane chemically bonded silica chromatographic column, a sodium octane sulfonate solution is taken as a mobile phase A, acetonitrile is taken as a mobile phase B, the detection wavelength is 275-285nm, the column temperature is 20-40 DEG C and the flow velocity is 0.9-1.1mL / min; and carrying out gradient elution, wherein the preparation method of the mobile phone A comprises the steps of taking sodium octane sulfonate and monopotassium phosphate, dissolving and diluting the sodium octane sulfonate and the monopotassium phosphate to 1000mL by using water; and adding 5mL of trimethylamine and adjusting the pH value to be 2.6-3.0 by using a phosphoric acid. The method is capable of effectively separating the naphazoline hydrochloride and the related substances thereof, and is good in separation degree, thereby effectively controlling the quality of the naphazoline hydrochloride.

Description

(1) Technical field [0001] The invention relates to the technical field of chemical drug analysis methods, in particular to a detection method for naphazoline hydrochloride and related substances. (2) Background technology [0002] As we all know, the impact of drug purity on patients is very large. Impurity of injected drugs is the main cause of adverse drug reactions (such as allergies, drug fever, etc.). Impure oral drugs may increase the incidence of adverse reactions, such as nausea, vomiting, abdominal pain, and diarrhea. At the same time, it may affect the absorption of drugs, thereby affecting the efficacy of drugs. Therefore, the detection method of drug purity is particularly important. Related substances (Telated substances) refer to the starting materials, reagents, intermediates, by-products and other substances brought in during the production of raw materials And special impurities such as degradation products, polymers or crystal transformations generated ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 董海霞刘建洋甄爱华邢科刘学艳
Owner 山东绅联药业股份有限公司
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