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A kind of detection method of capecitabine related substances

A capecitabine and detection method technology, applied in measurement devices, instruments, scientific instruments and other directions, can solve problems such as difficulty in effective detection, impurity E cannot be effectively separated, etc., and achieves easy operation, accurate and reliable detection results. , the special effect

Active Publication Date: 2022-07-22
CHONGQING SHENGHUAXI PHARMA CO LTD +1
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Problems solved by technology

[0025] At present, the United States Pharmacopoeia, European Pharmacopoeia, and domestic literature (Chinese Journal of New Drugs, 2015, 24 (16), 1902-1910; Strait Pharmacy 2013, 25 (1), 48-50) all have proposed detection of related substances of capecitabine. There are detection methods, but neither the impurity D nor the impurity E in the above impurities can be effectively separated, and it is difficult to effectively detect these two impurities in the actual amount of the raw material drug

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  • A kind of detection method of capecitabine related substances
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  • A kind of detection method of capecitabine related substances

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Embodiment 1

[0059] 1. Detection conditions

[0060] According to high performance liquid chromatography (Chinese Pharmacopoeia 2015 edition general rule 0512), Boltimate EXT-PFP was used, 2.7μm 4.6×250mm column was used, and methanol-acetonitrile-0.1% trifluoroacetic acid solution (4:1:15) was used as Mobile phase A; methanol-acetonitrile-0.1% trifluoroacetic acid solution (18:1:1) is mobile phase B, as follows:

[0061]

[0062] Gradient elution was performed, the flow rate was 1.0 mL per minute, the column temperature was 40°C, and the detection wavelength was 250 nm.

[0063] 2. Preparation of sample solution

[0064] Take an appropriate amount of capecitabine, dissolve and dilute it with a diluent (methanol:acetonitrile:water 4:1:15) to prepare a sample containing 0.3mg per 1ml, as the test solution.

[0065] Another appropriate amount of capecitabine reference substance was taken, dissolved with diluent and diluted to make a solution containing 0.15 μg per 1 mL, as the reference...

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Abstract

The invention discloses a detection method for capecitabine related substances: the method adopts high performance liquid chromatography for detection, and includes the following steps: Step 1. Prepare a capecitabine sample solution, the capecitabine The sample solution includes capecitabine test solution and capecitabine control solution; step 2, inject the sample solution obtained in step 1 into a high performance liquid chromatograph, and use mobile phase A and mobile phase B as mobile phases for gradient elution , and record the chromatogram. The detection method adopts a pentafluorophenyl bonded silica gel chromatographic column. The detection method is easy to operate, the retention time of the main peak of capecitabine is suitable, the defects of the prior art are overcome, the impurity D and the impurity E are effectively separated, other known impurities can be effectively detected, and the separation degree is high. It has strong specificity and accurate and reliable detection results, which provides a simple and reasonable detection method for the quality control and impurity research of capecitabine.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to the separation of related substances of antitumor drug capecitabine, and in particular to a method for detecting the related substances of capecitabine. Background technique [0002] Capecitabine is a fluoropyrimidine deoxynucleoside carbamate anti-tumor drug developed by Roche, Switzerland. Colorectal cancer, in combination with docetaxel for metastatic breast cancer. The drug was launched in China in 2001, and in August 2008, the China Food and Drug Administration approved it for the treatment of advanced gastric cancer. Capecitabine has been widely used in many countries at home and abroad for the treatment of the above-mentioned cancers. The chemical name of capecitabine is: 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine, and the chemical structure is as follows: [0003] . [0004] The synthetic route of capecitabine currently used for production is as follows: ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 王庆魏仙
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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