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Method for separating and purifying unknown impurities in warfarin original drug sample

A technology for separation and purification of unknown impurities, applied in the field of pharmaceutical analysis, can solve the problems of complicated separation and purification methods, and achieve the effect of good test, high precision and low detection cost

Inactive Publication Date: 2020-06-09
上海洲锐生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, in the prior art, the methods for separating and purifying unknown impurities in warfarin raw drug samples are relatively complicated, so it is a research hotspot for those skilled in the art to study an accurate, fast, high-sensitivity, and high-repeatability analysis method

Method used

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  • Method for separating and purifying unknown impurities in warfarin original drug sample
  • Method for separating and purifying unknown impurities in warfarin original drug sample
  • Method for separating and purifying unknown impurities in warfarin original drug sample

Examples

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Embodiment 1

[0056] Embodiment 1 provides a method for separating and purifying unknown impurities in the original drug sample of warfarin, comprising the following steps:

[0057] (1) Weigh the former drug of warfarin to be detected, add a solvent to dissolve, and obtain the former drug solution of warfarin;

[0058] (2) Inject warfarin technical solution into the chromatograph for detection, and control its injection volume, ultraviolet detection wavelength, chromatographic column, column temperature, mobile phase and flow rate to obtain the result.

[0059] The solvent described in step (1) is DMF and acetonitrile, wherein the volume ratio of DMF and acetonitrile is 1:4.

[0060] The concentration of the Warfarin technical solution is 220mg / mL; the injection volume is 12mL.

[0061] The ultraviolet detection wavelength is 300nm.

[0062] The chromatographic column is Waters Xbridge C18, with a length of 250 mm, an inner diameter of 30 mm, and a particle size of 10 μm.

[0063] The mo...

Embodiment 2

[0068] The difference from Example 1 is that the mobile phase is a gradient elution within 0 to 30 min. At 0 min, the volume ratio of acetonitrile and sodium dihydrogen phosphate solution is 1:9; at 30 min, the volume ratio of acetonitrile and dihydrogen phosphate The volume ratio of sodium aqueous solution is 7:3.

Embodiment 3

[0070] The difference from Example 1 is that the mobile phase is a gradient elution within 0 to 30 min. At 0 min, the volume ratio of acetonitrile and sodium dihydrogen phosphate solution is 1:9; at 30 min, the volume ratio of acetonitrile and dihydrogen phosphate The volume ratio of sodium aqueous solution is 8:2.

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Abstract

The invention relates to the field of pharmaceutical analysis, and particularly discloses a method for separating and purifying unknown impurities in a warfarin original drug sample. The method at least comprises the following steps: weighing a warfarin original drug to be detected, and adding a solvent to dissolve the warfarin original drug to be detected to obtain a warfarin original drug solution; secondly, injecting the warfarin original drug solution into a chromatographic instrument for detection, and controlling the sample size thereof, ultraviolet detection wavelength, chromatographiccolumn, column temperature, mobile phase and flow rate of such that the impurities in the warfarin original drug sample can be effectively separated, and an analysis method has the advantages of highseparation efficiency, high analysis speed and high detection sensitivity.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for separating and purifying unknown impurities in warfarin raw drug samples. Background technique [0002] Preparative liquid chromatography is a separation technique for the purpose of obtaining pure samples. Since it was applied to the separation of pigments in the 1930s, it has made great progress. In the 1980s, high-performance preparative liquid chromatography developed rapidly in the pharmaceutical industry, and in the 1990s, it was widely used in the separation and purification of proteins. Today, preparative chromatography is used in almost every field of social production and life, such as the separation and purification of secondary metabolites, natural products, macromolecular compounds, and some important pharmaceutically active proteins, biotherapeutics, and diagnostic reagents. [0003] However, in the prior art, the methods for separating and purifying unkno...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 周晓渭
Owner 上海洲锐生物科技有限公司
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