Method for detecting contents of carboplatin and related substances in carboplatin and carboplatin injection

A detection method and technology for related substances, applied in the field of quantitative analysis, can solve the problems of no stability indicating ability, low impurity detection ability, low column efficiency of carboplatin main peak, etc., so as to improve the detection ability, stability indicating ability and accuracy Good, improve the effect of retention performance

Inactive Publication Date: 2014-08-20
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its disadvantages are that the main peak of carboplatin has low column efficiency, fast peak eluting, low impurity detection ability, and no stability indication ability

Method used

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  • Method for detecting contents of carboplatin and related substances in carboplatin and carboplatin injection
  • Method for detecting contents of carboplatin and related substances in carboplatin and carboplatin injection
  • Method for detecting contents of carboplatin and related substances in carboplatin and carboplatin injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A method for detecting carboplatin content and related substances in carboplatin injection, using high performance liquid chromatography, using NUCLEODUR C18Pyramid chromatographic column, the particle size of the filler is 5 μm, and the specification is 250mm×4.6mm. Gradient elution was performed with mobile phase A and mobile phase B, time (min) / mobile phase B (v%): 0 / 0; 10 / 0; 35 / 100; 40 / 100; 41 / 0; 55 / 0. The flow rate is 0.4mL / min, the column temperature is 30°C, and the detection wavelength is 220nm;

[0031] Described mobile phase A is tetrabutylammonium bisulfate buffer, gets 20mL and adds water and dilutes to 1000mL;

[0032] The mobile phase B is tetrabutylammonium bisulfate buffer, 20mL is diluted with water to 750mL, and 250mL of acetonitrile is added;

[0033] The tetrabutylammonium hydrogensulfate buffer solution is 8.5g tetrabutylammonium hydrogensulfate, add 80mL water to dissolve, then add phosphoric acid 3.4mL, finally adjust the pH value to 7.7 with 10m...

Embodiment 2

[0036] A method for detecting carboplatin content and related substances in carboplatin injection, using high performance liquid chromatography, using YMC Triart C18, chromatographic column, the particle size of the filler is 5 μm, and the specification is 250mm×4.6mm. , Gradient elution with mobile phase A and mobile phase B, time (min) / mobile phase B (v%): 0 / 0; 10 / 0; 35 / 100; 40 / 100; 41 / 0; 55 / 0 . The flow rate is 0.5mL / min, the column temperature is 25°C, and the detection wavelength is 220nm;

[0037] Described mobile phase A is tetrabutylammonium bisulfate buffer, gets 20mL and adds water and dilutes to 1000mL;

[0038] The mobile phase B is tetrabutylammonium bisulfate buffer solution, 20mL is diluted with water to 750mL, and 240mL of acetonitrile is added;

[0039] The tetrabutylammonium hydrogensulfate buffer solution is 8.5g tetrabutylammonium hydrogensulfate, add 80mL water to dissolve, then add phosphoric acid 3.4mL, finally adjust the pH value to 7.5 with 10mol / mL ...

Embodiment 3

[0042]A method for detecting carboplatin content and related substances in carboplatin injection, using high performance liquid chromatography, using YMC Triart C18, the particle size of the filler is 5 μm, and the specification is 250mm×4.6mm. Gradient elution with mobile phase A and mobile phase B, time (min) / mobile phase B (v%): 0 / 0; 10 / 0; 35 / 100,; 40 / 100,; 41 / 0; 55 / 0. The flow rate is 0.6mL / min, the column temperature is 30°C, and the detection wavelength is 220nm;

[0043] Described mobile phase A is tetrabutylammonium bisulfate buffer, gets 20mL and adds water and dilutes to 1000mL;

[0044] The mobile phase B is tetrabutylammonium bisulfate buffer, 20mL is diluted with water to 750mL, and 260mL of acetonitrile is added;

[0045] The tetrabutylammonium hydrogensulfate buffer solution is 8.5g tetrabutylammonium hydrogensulfate, add 80mL water to dissolve, then add phosphoric acid 3.4mL, finally adjust the pH value to 7.3 with 10mol / mL sodium hydroxide solution;

[004...

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Abstract

The invention discloses a method for detecting contents of carboplatin and related substances in carboplatin and a carboplatin injection. The method comprises the steps: selecting an octadecyl silane bonded silica gel chromatographic column by adopting a high performance liquid chromatography, performing gradient elution by using a mobile phase A and a mobile phase B, wherein the flow speed is 0.4-0.6 mL / min, the column temperature is 25-30 DEG C, and the detection wavelength is 220 nm; and collecting 20 mL of tetrabutylammonium hydrogen sulfate buffer solution as the mobile phase A, diluting to 1000 mL by adding water; collecting 20 mL of tetrabutylammonium hydrogen sulfate buffer solution as the mobile phase B, diluting to 750 mL by adding water, adding 240-260 mL of acetonitrile, wherein the tetrabutylammonium hydrogen sulfate buffer solution is formed by adopting the steps of dissolving 8.5 g of tetrabutylammonium hydrogen sulfate by adding 80 mL of water, adding 3.4 mL of phosphoric acid, and finally adjusting a pH value to 7.3-7.7 by using 10 mol / mL sodium hydroxide liquid; and performing gradient elution by using the mobile phase A and the mobile phase B, ratios of time (min) / mobile phase B (v%) are 0 / 0, 10 / 0, 35 / 100, 40 / 100, 41 / 0 and 55 / 0. Compared with the prior art, the method disclosed by the invention is remarkably improved in retention property, and has the characteristics of strong specificity, high sensitivity, and good accuracy.

Description

technical field [0001] The invention relates to a quantitative analysis method, in particular to a high performance liquid chromatography method for carboplatin and carboplatin content in carboplatin injection and related substances. Background technique [0002] Carboplatin is the second-generation platinum-based antitumor drug after cisplatin. It was discovered by Clear et al. in 1980, and it was first launched in the UK in 1986. It was approved by the US FDA in 1989. The English name is Carboplatin, and the chemical name is cis-1,1 -Cyclobutanedicarboxylic acid-diammine platinum (Cis-1,1-cyclobutandicarboxylacid-diammine platinum). The chemical structural formula is: [0003] [0004] Carboplatin has good water solubility and is made into injection solution with water for injection. It is mainly used for advanced ovarian cancer, testicular cancer, head and neck cancer, lung cancer, etc. who cannot tolerate vomiting caused by cisplatin treatment. The most commonly used...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 张光宪丁兆孙朝国胡刚
Owner SICHUAN HUIYU PHARMA
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