Liquid chromatography detection method of BC-02

A BC-02, liquid chromatography technology, applied in the field of BC-02 liquid chromatography detection, can solve the problems of no analysis method and related research, achieve rapid detection, shorten analysis time, and improve the effect of theoretical plate number

Inactive Publication Date: 2015-05-27
SHANDONG UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no analytical method and related research for the quality standard control of this new type of drug

Method used

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  • Liquid chromatography detection method of BC-02
  • Liquid chromatography detection method of BC-02
  • Liquid chromatography detection method of BC-02

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 BC-02 content detection

[0036] 1. Reagents and solutions

[0037] 1. BC-02 standard product: purity ≥ 99.0%.

[0038] 2. BC-02 standard solution: Take 10.05 mg of BC-02 standard product, accurately weigh it (accurate to 0.0001 g), put it in a 10 mL volumetric flask, dissolve it in water and dilute to the mark, the concentration of this solution is 1 mg / mL.

[0039] 3. System suitability test: Take 100μl of 0.5mg / ml 5-Fu aqueous solution and 10mg BC-02 with water and dilute to volume into a 10ml volumetric flask to prepare a system suitability solution.

[0040] 2. Instruments and equipment

[0041] 1. Analytical balance: the sensitivity is 0.0001g.

[0042] 2. Microporous membrane: pore size 0.45μm.

[0043] 3. High performance liquid chromatography (equipped with UV detector).

[0044] 3. Analysis steps

[0045] 1. Liquid Chromatography Conditions

[0046] Chromatographic column: phenomenex (or choose a C18 column with equivalent filler, which is sui...

Embodiment 2

[0070] Impurity detection in embodiment 2 BC-02

[0071] 1. Reagents and solutions

[0072] 1. BC-02 standard product: purity ≥99.0%.

[0073] 2. 5-Fu standard product: purity ≥ 99.0%.

[0074] 3. Mixed standard solution: Weigh 5.12mg of 5-Fu and dilute with water into a 10ml volumetric flask (0.5mg / ml), weigh 10.07mg of BC-02 into a 10ml volumetric flask, dilute with water to volume. Take 100 microliters of each of the above two solutions and place them in the same 10ml volumetric flask, dilute with water to obtain a mixed standard solution with a concentration of 5.12 μg / ml of 5-Fu and a concentration of BC-02 of 10.07 μg / ml.

[0075] 4. System suitability test: Take 100μl of 0.5mg / ml 5-Fu aqueous solution and 10mg BC-02 with water and dilute to volume into a 10ml volumetric flask to prepare a system suitability solution.

[0076] 2. Instruments and equipment

[0077] 1. Analytical balance: the sensitivity is 0.0001g.

[0078] 2. Microporous membrane: pore size 0.45μm. ...

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Abstract

The invention belongs to the field of analytical chemistry detection, and particularly relates to a liquid chromatography detection method of BC-02. According to the method, methanol-water is taken as a phase A, and acetonitrile-water-trifluoroacetic acid (TFA)-triethylamine (TEA) which is a moving phase is taken as a phase B; due to appropriate proportion adjustment, the requirement of the separation degree of the BC-02 and the adjacent impurity peak can be met, and main degradation products including hydroxymethyl 5-Fu and 5-Fu can be well separated. Under the same chromatographic condition, the method not only is capable of rapidly detecting the content of the BC-02, but also is capable of detecting the isomer of the BC-02 as well as impurities with structures which are the similar to that of the BC-02 at the same time; after the method is used, the proper sample solution concentration is determined, the lower limit of detection is reduced, and quantitative analysis can be well carried out when the concentration of the detected target is lower, so that the detection method has higher practical application values; furthermore, the method is simple and easy to operate, an auxiliary reagent is low in price and easy to obtain, and the detection results are real and reliable; therefore, the method is a rapid and accurate quantitative detection method.

Description

technical field [0001] The invention belongs to the field of analytical chemistry detection, and in particular relates to a liquid chromatography detection method of BC-02. Background technique [0002] BC-02 (Bestatin-5Fu derivative) is a new anti-tumor drug independently developed by Shandong University School of Pharmacy. By combining Ubenimex, which inhibits tumor stem cells, with the cytotoxic anti-tumor drug 5-fluorouracil (5-Fu), they can synergistically exert their curative effect and achieve multi-target anti-tumor effects, opening up new opportunities for the research of new anti-tumor drugs. new area. [0003] Recent studies have shown that in mice with liver cancer xenografts, comparing the use of ubenimex, 5-fluorouracil and the combination of the two drugs, it was found that the combined group showed extremely high tumor inhibitory activity. The results of this study provide good experimental evidence for the combined application of ubenimex with 5-fluorourac...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 徐玉文丁钦阁徐文方李玉梅李军
Owner SHANDONG UNIV
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