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High performance liquid chromatography determination method of dihydroartemisinin content

A high-performance liquid chromatography and dihydroartemisinin technology, applied in measuring devices, instruments, scientific instruments, etc., to achieve good reproducibility, stable sum of double peak areas, and improved accuracy and reliability

Active Publication Date: 2014-04-30
重庆市食品药品检验所
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0006] At present, there is no method for the accurate determination of dihydroartemisinin content by high performance liquid chromatography

Method used

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  • High performance liquid chromatography determination method of dihydroartemisinin content
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  • High performance liquid chromatography determination method of dihydroartemisinin content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Precisely weigh 25.22mg of dihydroartemisinin reference substance, put it in a 25ml measuring bottle, add an appropriate amount of acetonitrile-water (60:40), dissolve it by ultrasonic treatment, dilute to the mark, shake well, and use it as the test solution; Inject 20 μl into the liquid chromatograph and record the chromatogram. Octadecylsilane bonded silica gel (CAPCELL PAK C18MGⅡ, 100mm×4.6mm, 3μm) was used as filler; acetonitrile-water (60︰40) was used as mobile phase; detection wavelength was 216nm; flow rate was 0.6ml / min. The chromatographic peak area of ​​dihydroartemisinin was measured at 0min, 10min, and 20min respectively, and the high-performance liquid chromatogram is as follows Figure 1~3 shown. The chromatographic peaks of dihydroartemisinin all showed double peaks. according to Figure 1~3 Calculate the RSD% of the sum of the chromatographic peak areas and the RSD% of the ratio of the chromatographic peak areas, and the results are shown in Table 1....

Embodiment 2

[0032] Accurately weigh 40.12 mg of dihydroartemisinin reference substance, put it in a 10ml measuring bottle, add an appropriate amount of dimethyl sulfoxide, shake to dissolve, dilute to the mark, shake well, and use it as the test solution; accurately measure 5 μl of injection solution Phase chromatograph, record the chromatogram. Octadecylsilane bonded silica gel (CAPCELL PAK C18MGⅡ, 100mm×4.6mm, 3μm) was used as filler; acetonitrile-water (60︰40) was used as mobile phase; detection wavelength was 216nm; flow rate was 0.6ml / min. The chromatographic peak area of ​​dihydroartemisinin was measured at 0min, 10min, and 20min respectively, and the high-performance liquid chromatogram is as follows Figure 4~6 shown. The chromatographic peak of dihydroartemisinin was doublet. according to Figure 4~6 Calculate the RSD% of the sum of the chromatographic peak areas and the RSD% of the ratio of the chromatographic peak areas, and the results are shown in Table 2. It can be seen ...

Embodiment 3

[0036] Accurately weigh 40.33 mg of dihydroartemisinin raw material drug sample, put it in a 10ml measuring bottle, add an appropriate amount of dimethyl sulfoxide, shake to dissolve, dilute to the mark, shake well, and use it as a test solution; accurately measure 5 μl Inject into the liquid chromatograph and record the chromatogram. Octadecylsilane bonded silica gel (EC100 / 4.6NUCLEOSIL100-3C18, 3μm, 4.6×100mm) was used as filler; acetonitrile-water (60︰40) was used as mobile phase; detection wavelength was 216nm; flow rate was 0.6ml / min. Samples were injected at 0 min, 10 min, and 20 min to measure the chromatographic peak area of ​​dihydroartemisinin. The chromatographic peak of dihydroartemisinin was double-peaked, and the sum of the peak areas was stable. The calculated RSD% of the chromatographic peak area was 0.45 %.

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Abstract

The invention aims to provide a high performance liquid chromatography determination method of dihydroartemisinin content. According to the determination method, the dihydroartemisinin content is determined by high performance liquid chromatography through dissolution of dimethylsulfoxide, wherein dihydroartemisinin is a single isomer in dimethylsulfoxide. When liquor enters a moving phase, the isomer begins to convert and balance, and the chromatographic peak is double peaks. As the appearance time (converting and balancing time of the isomer) is precise and controllable, the sum of the areas of the double peaks is stable and the repeatability is good, so that the demand on precision of determination is satisfied. The determination method provided by the invention avoids the defect that the content determination precision is low due to conversion of the isomer and unstable and uncontrollable sum of the areas of the double peaks of dihydroartemisinin in other solvents, improves the accuracy and reliability of the content determination result of dihydroartemisinin, and provides a scientific basis for establishing a stable, reliable and comprehensive quality control method for dihydroartemisinin.

Description

technical field [0001] The invention belongs to the field of drug analysis; more specifically, the invention relates to a method for determining the content of dihydroartemisinin by high performance liquid chromatography. Background technique [0002] As one of the main derivatives of artemisinin, dihydroartemisinin is formed by reducing artemisinin with sodium tetrahydroborate. It is one of the main active forms of artemisinin drugs in the body. It has better water solubility, It has the advantages of fast absorption, rapid excretion and metabolism, high efficiency and low toxicity. Dihydroartemisinin has great advantages in controlling malaria symptoms, treating cerebral malaria and anti-chloroquine resistant strains of falciparum malaria. The commonly used methods for the determination of dihydroartemisinin content are ultraviolet spectrophotometry and high performance liquid chromatography, the latter is also the content determination method included in the "Chinese Pha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王白露曾令高梁静张伟
Owner 重庆市食品药品检验所
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