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Capecitabine determination and application thereof

A capecitabine and determination method technology, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve problems such as interference of n-amyl alcohol content, and achieve the effects of low equipment requirements, simple operation and quality assurance

Active Publication Date: 2016-08-03
HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Solved the problem of interference of capecitabine samples to the determination of n-pentanol content due to high temperature degradation

Method used

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  • Capecitabine determination and application thereof
  • Capecitabine determination and application thereof
  • Capecitabine determination and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Chromatographic conditions for direct injection method:

[0060] Column temperature: programmed temperature rise: the initial temperature is 60°C and kept for 2 minutes, then the temperature is raised to 200°C at a rate of 15°C per minute and kept for 5 minutes.

[0061] Injection port temperature: 70°C;

[0062] Flame ionization detector temperature: 250°C;

[0063] Carrier gas: nitrogen;

[0064] Carrier gas flow rate: 2.7ml / min;

[0065] Split ratio: 10:1.

[0066] 1. Detection

[0067] A, preparation of test solution: get capecitabine sample, dissolve and be diluted into the solution of 0.01g / ml with dichloromethane, mix, and set aside;

[0068]B, preparation of reference substance solution: get the residual solvent sample in capecitabine, dilute with dichloromethane solution to make a 500 μg / ml solution, mix well, and set aside;

[0069] C, detection method: get each 1 μ l of need testing solution and reference substance solution, inject in the gas chromatogr...

Embodiment 2

[0112] In the same way as in Example 1, the solvent for adjusting need testing solution and reference substance solution is acetone;

[0113] Injection port temperature: 60°C;

[0114] Flame ionization detector temperature: 180°C;

[0115] Carrier gas flow rate: 2.2ml / min;

[0116] Split ratio: 5:1.

[0117] Three batches of test samples were detected according to the above-mentioned assay method, and the results are shown in Table 6.

[0118] Table 6: Test results of three batches of test products

[0119] batch number

Embodiment 3

[0121] In the same way as in Example 1, the solvent for adjusting need testing solution and reference substance solution is normal hexane;

[0122] Injection port temperature: 75°C;

[0123] Flame ionization detector temperature: 250°C;

[0124] Carrier gas flow rate: 3.2ml / min;

[0125] Split ratio: 15:1.

[0126] Three batches of test samples were detected according to the above-mentioned determination method, and the results are shown in Table 7.

[0127] Table 7: Test results of three batches of test products

[0128] batch number

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Abstract

The invention discloses capecitabine determination and application thereof. A direct injection method is selected, an organic solvent with the boiling point lower than 70 DEG C under the normal pressure is adopted as a solvent, the temperature of an injection port is 60-75 DEG C, degradation of capecitabine is effectively controlled, and the problem that a capecitabine sample disturbs determination of the content of n-amyl alcohol due to high-temperature degradation is solved. The verification test reproducibility is good, the linear relation is good, the average recovery rate is good, and n-amyl alcohol possibly remaining in the capecitabine sample can be accurately and quantitatively detected out. The content of n-amyl alcohol in the sample is accurately determined, and meanwhile the quality of capecitabine and safety of drug use are ensured.

Description

technical field [0001] The invention belongs to the technical field of medical analysis, and in particular relates to the determination and application of capecitabine. Background technique [0002] Capecitabine, English name Capecitabine, is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate drug that can be transformed into 5-FU in the body. It is developed by Roche and its trade name is Xeloda. It can inhibit cell Cleaves and interferes with RNA and protein synthesis. It is suitable for the further treatment of advanced primary or metastatic breast cancer that is ineffective in paclitaxel and chemotherapy regimens including anthracyclines. It is mainly used for the treatment of advanced primary or metastatic breast cancer, rectal cancer, colon cancer and gastric cancer. Its structural formula is as follows: [0003] [0004] Chinese invention patents CN201080032544.6, CN201010134093.9 and CN201110090029.X all used n-amyl alcohol in the preparation of cape...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/16G01N30/88
CPCG01N30/02G01N30/06G01N30/16G01N30/88G01N2030/025G01N2030/884
Inventor 朱叶芬雍春胡婷霞
Owner HANGZHOU HUADONG MEDICINE GRP PHARMA RES INST
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