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Quality control method of probucol

A technology of quality control method and detection method, which is applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of inability to directly detect 3 related substances, inability to detect specific content, quantification limit and detection line separately, and achieve results. Stable and reliable, the method is simple and easy to implement, and the detection cost is low.

Inactive Publication Date: 2020-09-18
山东同其信息科技有限公司
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  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Fang Shuqing and others disclosed a method for the detection of related substances of probucol. The HPLC method used did not disclose the specific chromatographic conditions. The experimental results showed that the three related substances could not be detected more directly, and A, B, and C could not be detected separately. The specific content can only limit the total amount of related substances
[0008] An Zhenzhen et al disclosed a method for the simultaneous determination of three related substances in probucol tablets by RP-HPLC. The recovery rate was between 80-120%, and the total detection time was 70 minutes. The limit of quantification and detection line are high, which is not conducive to the promotion of the method

Method used

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  • Quality control method of probucol
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Experimental program
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Embodiment 1

[0111] (1) Chromatographic conditions:

[0112] Chromatographic column: Agilent C18 column, specification 4.6×150mm, 3.5µm; column temperature: 35°C; mobile phase flow rate: 0.6mL / min, detection wavelength: 246nm (probucol and impurity B); 420nm (impurity A, Impurity C), injection volume: 20µL.

[0113] Mobile phase: The mixed solution of methanol-acetonitrile (80:20 by volume) is used as mobile phase A, and acetic acid-ammonium acetate with pH 4.5 is used as mobile phase B. The gradient elution program is set as:

[0114] time (min) A (volume%) B (volume%) 0 55 45 10 65 35 28 80 20 33 80 20 40 55 45

[0115] (2) Solution preparation:

[0116] Weigh 5 mg of probucol reference substance, impurity A, impurity B, and impurity C respectively, add a mixture of n-hexane and isopropanol (7:3 by volume) to dissolve and dilute to the mark, take 1 mL each and dilute step by step Method, dilute to 50 / 0.1, 10, 50mg / L respectively with mob...

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Abstract

The invention belongs to the technical field of drug analysis. The invention discloses a high performance liquid chromatography separation and determination method for impurities in a probucol bulk drug and a preparation and application. The method is used for simultaneously separating impurities (2,2',6,6'-tetratert-butyldibenzoquinone), impurities B (4,4'-dithiobis(2,6-di-tert-butylphenol) and impurities C ((4-[(3,5-di-tert-butyl-2-hydroxyphenylthio)isopropyl mercaptan]-2,6-di-tert-butylphenol). According to the method, octadecylsilane chemically bonded silica is adopted as a chromatographiccolumn of a filler to prepare a reference substance solution and a test solution, the reference substance solution and the test solution are injected into a liquid chromatograph, an organic phase anda buffer salt solution in a certain proportion are adopted as mobile phases, and bulk drugs in the bulk drugs and related preparations and probucol, impurities A, impurities B and impurities C in thepreparations can be ensured to be completely separated. The method is short in analysis time, provides an effective quality control method for research, development and production of probucol bulk drugs and related preparations, and has popularization value.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a quality control method of probucol. Background technique [0002] Hypercholesterolemia (Hypercholesterolemia) is a common metabolic disease. Clinical examination data show that the concentration of triglyceride and low-density lipoprotein cholesterol (low density lipoprotein cholesterol, LDL-C) in the patient's blood increases, and the concentration of high-density lipoprotein cholesterol ( Decreased high density lipoprotein cholesterol (HDL-C) concentration is one of the independent risk factors for atherosclerotic diseases such as coronary heart disease (CHD), ischemic stroke, and lower extremity vascular disease. [0003] Probucol, chemical name is 4,4'-[(1-methylethyl)dithio]bis[(2,6-di-tert-butyl)phenol], molecular formula is C31H48O2S, molecular weight is 516.84, The CAS number is 23288-49-5. [0004] The indication of probucol is hypercholesterolemia....

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675G01N2030/047
Inventor 田朋鑫宿高明潘晓春
Owner 山东同其信息科技有限公司
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