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High performance liquid chromatography for detecting content of beta-artemether and related substances

A technology of artemether and content, which is applied in the field of drug analysis, can solve the problems of low test efficiency and achieve the effect of quantitative detection, fast peak extraction and high detection efficiency

Pending Publication Date: 2022-03-15
ZHANG JIA GANG VINSCE BIO PHARM
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the process of using the β-artemether method of the Chinese Pharmacopoeia and the International Pharmacopoeia, if the impurity needs to be tested, when the main peak of β-artemether is about 8 minutes, the retention time of the impurity is about 50 minutes, and the test efficiency low

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  • High performance liquid chromatography for detecting content of beta-artemether and related substances
  • High performance liquid chromatography for detecting content of beta-artemether and related substances
  • High performance liquid chromatography for detecting content of beta-artemether and related substances

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Experimental program
Comparison scheme
Effect test

Embodiment approach

[0074] Solution preparation:

[0075] Take about 100mg of β-artemether reference substance, put it in a 10mL volumetric flask, add acetonitrile-water (1:1) to dissolve and dilute to the mark, shake well as the reference substance solution.

[0076] Take about 100mg of the test sample, put it in a 10mL volumetric flask, add acetonitrile-water (1:1) to dissolve and dilute to the mark, shake well as the test solution.

[0077] Assay:

[0078] Precisely measure the test solution and the reference solution, inject them into the liquid chromatograph respectively, and record the chromatograms. Calculate the content of the test product by the peak area according to the external standard method, and calculate the content of the related substances in the test product by the area normalization method.

Embodiment 1

[0080] Experimental materials: β-artemether working reference substance, artemisinin working reference substance, dihydroartemisinin working reference substance (α-dihydroartemisinin, β-dihydroartemisinin), α-artemisinin Working controls. These working reference substances were synthesized and refined by the R&D department of the company, and were calibrated by the QC department and the legal reference substances purchased by the China Institute for Food and Drug Control.

[0081] Experimental steps:

[0082] Take acetonitrile-water (1:1) as diluent, prepare β-artemether reference substance solution (10mg / mL), artemisinin reference substance solution (0.1mg / mL), dihydroartemisinin reference substance solution ( α-dihydroartemisinin 0.1mg / mL, β-dihydroartemisinin 0.1mg / mL), α-artemether reference solution (0.1mg / mL) and mixed solution (containing β-artemether 10mg / mL and other impurities each 0.05mg / mL). The above-mentioned solutions were sample-injected and tested successi...

Embodiment 2

[0088] Experimental materials: β-artemether working reference substance and β-artemether produced by Zhangjiagang Weisheng Biopharmaceutical Co., Ltd.

[0089] Experimental steps:

[0090] Take the β-artemether working reference substance and the β-artemether test substance, prepare the reference substance solution and the test solution according to the method under the implementation method, and prepare six test solution solutions in parallel. Two operators independently inspected twice, injected samples and recorded chromatograms. The content of the test substance measured by the two operators (see Table 3), from the test results, the precision measured between the two operators and the two operators is 0.62%, 0.37%, and 0.00%, respectively, and the precision is good.

[0091] Table 3: β-artemether precision test results

[0092]

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Abstract

The invention discloses a high performance liquid chromatography method for detecting the content of beta-artemether and related substances, and belongs to the technical field of pharmaceutical analysis. Firstly, the invention provides a method for rapidly detecting whether a sample containing beta-artemether contains an impurity A or not, and provides specific chromatographic conditions. According to the chromatographic conditions provided by the invention, the retention time of the impurity A is short, and the detection efficiency is high. Secondly, the invention also provides a method for synchronously detecting the content of impurities alpha-dihydroartemisinin, beta-dihydroartemisinin, artemisinin and alpha-artemether in beta-artemether by using the chromatographic conditions provided by the invention. The method provided by the invention not only realizes rapid detection of the sample containing the beta-artemether, but also realizes quantitative detection of impurities in the sample, and provides a scientific and efficient methodological basis for quality control of bulk drugs of the beta-artemether or some compositions and pharmaceutical preparations containing the beta-artemether.

Description

technical field [0001] The invention belongs to the technical field of drug analysis. Specifically, the present invention relates to a high-performance liquid chromatography method for detecting the content of β-artemether and related substances. Background technique [0002] β-artemether (see attached figure 1 ) molecular formula: C 16 h 26 o 5 , as white crystal or crystalline powder. β-artemether can be made into β-artemether tablets, β-artemether capsules and β-artemether injection, and can also be made into compound β-artemether tablets with lumefantrine. β-artemether is a high-efficiency and quick-acting killing agent for endogenous erythrocytes of Plasmodium. It is used for the treatment of chloroquine-resistant falciparum malaria and dangerous malaria, and the effect is rapid and the short-term curative effect is good. At present, with regard to the content of β-artemether and the inspection methods of related substances, both the Chinese Pharmacopoeia and the...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/74
CPCG01N30/02G01N30/74
Inventor 彭学东张梅赵金召陈亚平
Owner ZHANG JIA GANG VINSCE BIO PHARM
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