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A liquid-phase method for determining the content of cellulose in excipients in medicine

A technology of cellulose content and liquid phase method, which is applied in the directions of measuring devices, material separation, and material analysis, etc., which can solve the problems of unable to meet the monitoring requirements of cellulose content limit, low detection accuracy, cumbersome operation, etc.

Active Publication Date: 2022-03-08
广州国标检验检测有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] At present, the detection methods of cellulose are mostly acid-base alcohol ether method, iodometric method and colorimetric method, but these methods are cumbersome to operate and the detection accuracy is not high, which cannot meet the limited monitoring requirements of cellulose content in drugs

Method used

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  • A liquid-phase method for determining the content of cellulose in excipients in medicine
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  • A liquid-phase method for determining the content of cellulose in excipients in medicine

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Experimental program
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Effect test

Embodiment 1

[0032] The method for determining the cellulose content of the auxiliary material in the liquid phase method comprises the steps:

[0033] 1. Liquid chromatography conditions: Chromatographic column: TSKgtl G2000SW column, 60cm*7.5mm, 10μm; detector: charged aerosol detector; mobile phase: 10mmol / L ammonium acetate solution (pH 4.5): acetonitrile=95:5; Atomization temperature: 50°C; flow rate: 1.0ml / min; injection volume: 10μl.

[0034] 2. Reference substance solution: Accurately weigh 25.79 mg of hydroxyethyl cellulose reference substance, accurately weigh it, put it in a 50ml measuring bottle, add warm water (60°C) to dissolve it, add water to dilute to the mark, and shake well to obtain hydroxyethyl cellulose Ethyl cellulose reference substance stock solution. Then precisely pipette 5ml of the hydroxyethyl cellulose reference substance stock solution into a 10ml volumetric flask, dilute with water to the mark, and shake well to obtain the reference substance solution.

[...

Embodiment 2

[0039] The method for the determination of the cellulose content of excipients in drugs by liquid phase method was validated, and the validation results are as follows:

[0040] 1. Specificity: Get solvent water, reference substance solution, negative blank solution, need testing solution and standard-added need testing solution respectively and detect by the chromatographic conditions of embodiment 1, record chromatogram, investigate method specificity.

[0041] see results Figure 1~2 Shown, blank solution and negative blank solution ( figure 2 ) did not detect the target peak, no interference to the detection; the reference substance solution showed the target peak, and no other impurity peaks were detected ( figure 1 ); the test solution ( image 3 ) and the retention time of the target peak in the chromatogram of the standard-added test solution is consistent with the retention time of the main peak in the reference solution (retention time is between 10.483min~10.515m...

Embodiment 3

[0058] Detect reference substance solution and need testing solution respectively with reference to the method condition of embodiment, difference only is to adjust the pH of ammonium acetate solution to be 4.3 and 4.7, record chromatogram, calculate the hydroxyethyl cellulose concentration in reference substance solution and need testing solution content. The results showed that the pH value of the mobile phase fluctuated in the range of 4.3-4.7, the RSD of the peak area of ​​hydroxyethyl cellulose in the reference solution for 6 consecutive times was between 0.4% and 2.1%, and the RSD of the retention time was between 0.2 and 0.4%. The RSD of the hydroxyethyl cellulose content measured in the test solution was 2.7%, and the durability result met the requirements.

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Abstract

This application belongs to the technical field of drug analysis. The application provides a method for determining the content of cellulose as an excipient in medicine by a liquid phase method, comprising: respectively injecting the solution of the test product and the solution of the reference substance into a liquid chromatograph, and using a charge aerosol detector for content determination; wherein, the liquid The chromatographic column of the phase method is a gel chromatographic column, the mobile phase A of the liquid phase method is a salt solution, and the mobile phase B is acetonitrile. The determination method of the present application has been verified by specificity, linearity, repeatability, accuracy and stability, and the method can be used to accurately detect the content of cellulose in medicine.

Description

technical field [0001] The application belongs to the technical field of pharmaceutical analysis, and in particular relates to a liquid-phase method for determining the content of cellulose as an excipient in medicine. Background technique [0002] Pharmaceutical excipients refer to the excipients and additives used in the production of drugs and the preparation of prescriptions. They are indispensable components of drugs and are closely related to drug quality and drug safety. Generally, pharmaceutical excipients have passed a reasonable assessment in terms of safety, but as a chemical component, they are not completely inert, and are especially affected by the matrix of pharmaceutical ingredients. Some excipients are not only active, but may also exhibit toxic reactions. Therefore, it is necessary to monitor the content of pharmaceutical excipients. [0003] Cellulose is a kind of macromolecular polysaccharide composed of glucose. Due to its wide range of sources and uniq...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/72G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/7266G01N30/8675G01N2030/047
Inventor 陈新国左仕深黄军建郑秋灵廖均涛包瑶萍郑传奇蒋杰
Owner 广州国标检验检测有限公司
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