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Method for detecting content of hydroxychloroquine sulfate in hydroxychloroquine sulfate tablet

A technology of hydroxychloroquine sulfate tablets and hydroxychloroquine sulfate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that hydroxychloroquine sulfate tablets cannot be detected efficiently and quickly, the solvent is highly toxic, and the method is cumbersome and time-consuming. Efficient and fast effect

Pending Publication Date: 2022-07-08
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The embodiment of this application provides a detection method for the content of hydroxychloroquine sulfate in hydroxychloroquine sulfate tablets to solve the problem of detecting the main component hydroxychloroquine sulfate in hydroxychloroquine sulfate tablets in the related art. The existing method is cumbersome and time-consuming, and the solvent is highly toxic. Special attention should be paid to the operation. Labor protection, the technical problem of being unable to efficiently and quickly detect the content of hydroxychloroquine sulfate tablets

Method used

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

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Experimental program
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Effect test

Embodiment 1

[0054] To configure the sample analysis solution:

[0055] Precisely weigh about 12.5mg of hydroxychloroquine sulfate tablets, put them in a 25ml volumetric flask, add purified water to dissolve and dilute to the mark, shake well, and prepare a sample pre-prepared solution;

[0056] Precisely measure 5ml of the sample pre-prepared solution, put it in a 50ml volumetric flask, dilute it to the mark with purified water, shake well, and use it as the sample analysis solution.

[0057] Determination by high performance liquid chromatography:

[0058] Measure 10 μl of the sample analysis solution and inject it into a high performance liquid chromatograph for analysis and detection. The detection wavelength is 254 nm, and the chromatographic column used is a C18 column; The volume ratio scope of ammonium formate and acetonitrile in the mixed solvent is 70:30, and the flow rate of the mobile phase is 1.0 mL / min; wherein, the pH value scope of the ammonium formate solution adopted by ...

Embodiment 2

[0063] To configure the sample analysis solution:

[0064] Precisely weigh about 12.5mg of hydroxychloroquine sulfate tablets, put them in a 25ml volumetric flask, add purified water to dissolve and dilute to the mark, shake well, and prepare a sample pre-prepared solution;

[0065] Precisely weigh about 12.5mg of hydroxychloroquine sulfate tablets in 5ml, put them in a 25ml volumetric flask, add purified water to dissolve and dilute to the mark, shake well, and prepare a sample pre-prepared solution;

[0066] Precisely measure 5ml of the sample pre-prepared solution and place it in a 50ml volumetric flask, dilute to the mark with purified water, shake well, and use it as the sample analysis solution.

[0067] Determination by high performance liquid chromatography:

[0068]Measure 10 μl of the sample analysis solution and inject it into a high-performance liquid chromatograph for analysis and detection. The detection wavelength is 254 nm, and the chromatographic column used ...

Embodiment 3

[0072] To configure the sample and control analysis solutions:

[0073] Precisely weigh about 12.5mg of hydroxychloroquine sulfate reference substance, put it in a 25ml volumetric flask, add purified water to dissolve and dilute to the mark, shake well to prepare a reference substance pre-prepared solution;

[0074] Precisely measure 5ml of the reference substance pre-prepared solution and put it in a 50ml volumetric flask, dilute to the mark with purified water, shake well, and use it as a reference substance for analysis of the solution.

[0075] Determination by high performance liquid chromatography:

[0076] Measure 10 μl of the reference substance analysis solution and inject it into a high-performance liquid chromatograph for analysis and detection. The detection wavelength is 254 nm, and the chromatographic column used is a C18 column; the column temperature of the chromatographic column is 30 ° C, and the mobile phase is a mixture of ammonium formate-acetonitrile , t...

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Abstract

The invention relates to the technical field of drug analysis and detection, and provides a method for detecting the content of hydroxychloroquine sulfate in hydroxychloroquine sulfate tablets, and the method comprises the following steps: preparing a sample analysis solution from the hydroxychloroquine sulfate tablets; and analyzing the sample analysis solution by using a high performance liquid chromatography to determine the content of hydroxychloroquine sulfate in the hydroxychloroquine sulfate tablet. Wherein in the step of liquid chromatography, a used mobile phase is a mixed solvent composed of a buffer solution and an organic solvent, the buffer solution is an ammonium formate solution, the organic solvent is acetonitrile, and the volume ratio range of ammonium formate to acetonitrile in the mixed solvent is (80-87): (13-20). The invention provides a method for efficiently detecting the content of hydroxychloroquine sulfate in hydroxychloroquine sulfate tablets without solvent poison prevention labor protection.

Description

technical field [0001] The application relates to the field of drug analysis and detection, in particular to a method for detecting the content of hydroxychloroquine sulfate in hydroxychloroquine sulfate tablets. Background technique [0002] The main ingredient of hydroxychloroquine sulfate tablets is hydroxychloroquine sulfate, which is used to treat discoid lupus erythematosus and systemic lupus erythematosus. The drug standard of the State Drug Administration [WS-330(X-289)-99(1)] stipulates that the content determination method is repeated extraction with chloroform, and the extract is evaporated and concentrated, and then determined by non-aqueous alkali method. This method is tedious and time-consuming, and the solvent is highly toxic. Special attention should be paid to labor protection during operation, and the content of hydroxychloroquine sulfate tablets cannot be detected efficiently and quickly. SUMMARY OF THE INVENTION [0003] The embodiments of the present...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张萍钟怡罗雪晴文雯刘佩佩崔娟代梦琳
Owner GRAND PHARM (CHINA) CO LTD
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