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Method for detecting content of hydroxychloroquine sulfate

A technology of hydroxychloroquine sulfate and a detection method, which is applied in the field of medicine, can solve problems such as insufficient sensitivity and complex process, and achieve the effects of good stability and repeatability, simple operation, and good system applicability

Pending Publication Date: 2020-12-25
JIANGXI GUOYAO PHARMA LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The detection method in the existing drug registration standards adopts the titration method, and the preparation of the test solution uses chloroform extraction. Generally speaking, there are problems of complicated process and insufficient sensitivity

Method used

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  • Method for detecting content of hydroxychloroquine sulfate
  • Method for detecting content of hydroxychloroquine sulfate
  • Method for detecting content of hydroxychloroquine sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: use the method for high performance liquid chromatography to detect hydroxychloroquine sulfate content

[0050] Take 1L of purified water, add 0.02mol of dipotassium hydrogen phosphate (3.48g), dissolve and add phosphoric acid to adjust the pH to 6.0, take 350ml of the above solution, add 650ml of acetonitrile, mix well, and filter to obtain the mobile phase;

[0051] Take 500ml of acetonitrile, add 500ml of purified water, mix well, and prepare a diluted solution;

[0052] Take about 20 mg of hydroxychloroquine sulfate, accurately weighed, put in a 100ml measuring bottle, add acetonitrile water (1:1) to dissolve and dilute to the mark, shake well, accurately measure 5ml and put it in a 50ml measuring bottle, add acetonitrile water (1:1) 1) Dilute to the mark and shake well to prepare the test solution;

[0053]Take about 20mg of hydroxychloroquine sulfate reference substance, accurately weighed, put in a 100ml measuring bottle, add acetonitrile water (1:...

Embodiment 2

[0056] Embodiment 2: Dipotassium hydrogen phosphate solution and acetonitrile ratio investigation

[0057] Three mobile phases with volume ratios of 20:80, 35:65, and 50:50 were prepared using the 0.02 mol / L dipotassium hydrogen phosphate solution and acetonitrile prepared according to Example 1. The rest of the conditions are the same as in Example 1, and the resolution, main peak retention time and impurity peak quantity of different mobile phases are shown in Table 1.

[0058] Table 1 The resolution, main peak retention time and impurity peak quantity of different mobile phase ratios

[0059] Dipotassium hydrogen phosphate: acetonitrile Main peak retention time (min) Separation Number of impurity peaks 20:80 4.561 1.632 4 35:65 6.840 2.331 4 50:50 8.353 3.152 3

[0060] It can be seen that with the decrease of the organic phase in the mobile phase, the retention time of the main peak is prolonged, the separation between the main pea...

Embodiment 3

[0065] Embodiment 3: the investigation to dipotassium hydrogen phosphate solution concentration

[0066] Take 1L of purified water, add 0.01mol (1.74g), 0.02mol (3.48g) and 0.03mol (5.22g) of dipotassium hydrogen phosphate, dissolve and add phosphoric acid to adjust the pH to 6.0, take 350ml of the above solution, mix it with 650ml of acetonitrile, Three mobile phases were prepared separately. All the other conditions are the same as in Example 1. The resolution, retention time of main peak and number of impurity peaks of different mobile phases are shown in Table 2.

[0067] The degree of separation and main peak retention time and impurity peak quantity of different hydroxychloroquine sulfate solution concentration of table 2

[0068] Dipotassium hydrogen phosphate solution concentration (mol / L) Main peak retention time (min) Separation Number of impurity peaks 0.01 6.713 2.282 4 0.02 6.820 2.331 4 0.03 6.991 2.410 4

[0069] With ...

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Abstract

The invention relates to a method for detecting hydroxychloroquine sulfate. The method comprises the following steps of 1) preparation of a test sample solution, specifically, taking a hydroxychloroquine sulfate test sample, adding an acetonitrile-water mixed solution, dissolving and diluting; 2) preparation of a reference substance solution, specifically, dissolving a hydroxychloroquine sulfate reference substance in the acetonitrile-water mixed solution, and diluting; and 3) a determination method, specifically, measuring the reference substance solution and the test solution, injecting intoa high performance liquid chromatograph, recording a spectrogram, and calculating the content of the test hydroxychloroquine sulfate according to the peak area, wherein the chromatographic conditionsof the high performance liquid chromatography are as follows that octadecylsilane chemically bonded silica is used as a filler, a mobile phase is a mixed solution of a dipotassium phosphate solutionand acetonitrile in a volume ratio of 10 to 90-70 to 30, the flow rate is 0.8-1.2 ml / min, the detection wavelength is 244-264 nm, and the sample size is 5-50mu l. The method has the advantages of goodin the obtained component spike and resolution, simple in operation, high in precision, high in the recovery rate and good in the stability and repeatability.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a method for detecting the content of hydroxychloroquine sulfate. Background technique [0002] Chloroquine is a second-generation antimalarial drug. In the 1930s, German scientists synthesized and invented the synthetic antimalarial drug chloroquine, which has a chemical structure similar to natural quinine. It is safer and more effective than the first-generation antimalarial drug quinine, so it is widely used in the treatment and prevention of malaria. Due to the lack of testing and exploration of the safe range of drug dosage, the dosage of chloroquine was too large, more than ten times that needed to treat malaria, followed by serious adverse drug reactions—some patients had fundus diseases. [0003] Hydroxychloroquine is a second-generation semi-antimalarial drug. In 1944, scientists developed a new type of antimalarial drug, hydroxychloroquine, based on chloroquine. Hy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 刘娜赵鹏万义斌钟承赞左飞鸿葛友群杨明詹业奇庄庄钟佩敏吴鑫
Owner JIANGXI GUOYAO PHARMA LLC
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