Method for detecting related substances in chloroquine phosphate tablet

A technology of chloroquine phosphate tablets and detection methods, applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as difficult to obtain, relative retention time, relative response factor confirmation, and difficult to accurately evaluate drug quality, so as to avoid purchasing Expensive, good resolution, effective separation effect

Active Publication Date: 2020-06-12
GUANGZHOU BAIYUSN GUANGHUA PHARMA
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Problems solved by technology

When using TLC to detect related substances in the pharmacopoeias of various countries, they all use the method of gradient spotting of a series of reference substance solutions to "semi-quantitatively" evaluate the amount of impurities, but only limit the maximum impurity spot, and only by visual spot color It is difficult to make an accurate evaluation of the quality of drugs without any other specific requirements
In addition, in the current research literature on the detection of related substances in chloroquine phosphate tablets, Fang Wenzhi et al. (Chinese Journal of Pharmaceutical Industry. 1997, 28(12): 548-550) used gas chromatography, thin layer chromatography and other methods to determine the chloroquine phosphate The related substances of the raw materials are preliminarily determined to contain other isomers and deethylated substances in addition to the 5-chloro isomer in chloroquine phosphate, but only qualitative analysis has been carried out; Chen Zhukang et al. (China Pharmaceutical Industry Magazine. 2007,38 (5): 372-380) set up a kind of high performance liquid phase method (HPLC method) to measure the related substance of chloroquine phosphate with acetonitrile-potassium dihydrogen phosphate solution as mobile phase, but also only to the largest single Simple quantitative analysis of impurity and total impurity was carried out, but the relative retention time and relative response factor of each impurity were not confirmed
Therefore can not comprehensively and effectively measure the quality of chloroquine phosphate tablet quality
[0007] In addition, because the impurity reference substance is expensive and difficult to obtain, it is difficult to accurately determine the content of each known and unknown impurity only by self-control method (without correction factor)

Method used

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  • Method for detecting related substances in chloroquine phosphate tablet
  • Method for detecting related substances in chloroquine phosphate tablet
  • Method for detecting related substances in chloroquine phosphate tablet

Examples

Experimental program
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Embodiment 1

[0054] The detection method of related substance in embodiment 1 chloroquine phosphate tablet

[0055] 1. Chromatographic conditions: fill the chromatographic column with octadecylsilane bonded silica gel (the length of the chromatographic column is 150mm or 250mm, the inner diameter of the chromatographic column is 4.6μm, and the particle size of the chromatographic filler is 5μm); connect the ultraviolet detector in series The CAD detector is a detector, the ultraviolet detection wavelength is 260nm, the atomization temperature of the CAD detector is 35°C, and the output range is 100pA; with 0.1% (v / v) trifluoroacetic acid aqueous solution: acetonitrile (volume ratio) = 35:65 It is the mobile phase; the flow rate is 1.0ml / min; the column temperature is 30°C; the injection volume is 20μl.

[0056] The experimental steps are as follows:

[0057] (1) Preparation of the test solution: get the chloroquine phosphate tablet and grind it finely, accurately weigh an appropriate amou...

Embodiment 2

[0081] Embodiment 2: methodological investigation

[0082] 1. System adaptability inspection:

[0083] (1) Preparation of the test solution: get TF0006 batches of chloroquine phosphate tablets and grind finely, accurately weigh an appropriate amount (approximately equivalent to chloroquine phosphate 0.10g), put in a 50ml measuring bottle, dilute with mobile phase, ultrasonically dissolve, and settle to volume scale, shake well, filter, and get the continued filtrate to obtain the test solution;

[0084] (2) Preparation of system adaptability solution: take the above-mentioned test solution, irradiate it with an ultraviolet lamp at 365nm for 24 hours, pass through an organic filter membrane with a pore size of 0.45 μm, and obtain it;

[0085] (3) Preparation of contrast solution: precisely measure 1 ml of the test solution and put it in a 100 ml measuring bottle, add mobile phase to constant volume, shake well, and get final product;

[0086] (4) Reference substance solution:...

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Abstract

The invention relates to a method for detecting related substances in a chloroquine phosphate tablet. According to the method, the ultraviolet detector is connected with the electrospray detector (CAD) in series, so that the ultraviolet relative response factor of each impurity can be quickly, conveniently and accurately calculated, the content of known and unknown impurities in the chloroquine phosphate tablet can be accurately determined, the sensitivity and specificity of the method are high, and the effective control on related substances of the chloroquine phosphate tablet is realized. The method comprises the following steps: preparing a test solution, taking chloroquine phosphate tablets, dissolving the chloroquine phosphate tablets with a mobile phase, performing filtering, and taking subsequent filtrate as the test solution; preparing a system adaptive solution, namely taking the test solution, and irradiating the test solution by using an ultraviolet lamp to obtain the systemadaptive solution; preparing a contrast solution, namely diluting the test solution with a mobile phase to obtain the contrast solution; preparing a reference substance solution, namely dissolving achloroquine phosphate reference substance by using a mobile phase to obtain the reference substance solution; and injecting the system adaptive solution, the test solution, the reference solution andthe reference solution into a liquid chromatograph for determination.

Description

technical field [0001] The invention relates to the technical field of biomedical detection, in particular to a method for detecting related substances in chloroquine phosphate tablets. Background technique [0002] Chloroquine phosphate, chemical name: N,N-diethyl-N 4 -(7-Chloro-4-quinolyl)-1,4-pentanediamine diphosphate is composed of main ring 4,7-dichloroquinoline and side chain 2-amino-5-diethylaminopentane Made, the structural formula is as follows: [0003] [0004] Chloroquine phosphate is used for the treatment of chloroquine-sensitive falciparum malaria, vivax malaria and malaria malaria, and can be used for the suppressive prevention of malaria symptoms, and can also treat extraintestinal amoebiasis, connective tissue diseases, light-sensitive diseases (such as sun erythema), etc. In addition, in vitro experiments have shown that chloroquine has a good inhibitory effect on the new coronavirus; clinical results have initially shown that chloroquine phosphate ...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/78G01N30/34
CPCG01N30/88G01N30/78G01N30/34G01N2030/8872Y02A50/30
Inventor 邹洪平张俊华戴艳萍梁小雯董穗娟肖宵
Owner GUANGZHOU BAIYUSN GUANGHUA PHARMA
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