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Method for detecting content of optical isomers of bortezomib

A technology for optical isomers and detection methods, applied in measurement devices, scientific instruments, instruments, etc., can solve the obstacles of bortezomib optical isomer analysis and detection, affect drug quality analysis and quality control, and affect drug safety and effectiveness. and other issues to achieve the effect of ensuring safety and effectiveness

Active Publication Date: 2014-01-01
CHANGZHOU YABANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This brings obstacles to the analysis and detection of bortezomib optical isomers, affects the quality analysis and quality control of the drug, and then affects the safety and effectiveness of the drug

Method used

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  • Method for detecting content of optical isomers of bortezomib
  • Method for detecting content of optical isomers of bortezomib
  • Method for detecting content of optical isomers of bortezomib

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Instruments and Conditions:

[0028] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0029] Chromatographic column: AD-H (Chiralpak, 250×4.6mm, 5μm);

[0030] Mobile phase: n-hexane: ethanol: methanol: diethylamine=95:2.5:2.5:0.2

[0031] Detection wavelength: 270nm

[0032] Flow rate: 1.2ml / min

[0033] Column temperature: 35°C

[0034] Injection volume: 20μl

[0035] Experimental steps:

[0036] Take about 10 mg of bortezomib, bortezomib enantiomer, diastereoisomer A and diastereoisomer B respectively, put them in 10ml measuring bottles, add about 0.3ml of methanol for ultrasonic treatment to dissolve, add flow Dilute to the mark, shake well, take the above solutions and mix them in equal amounts as the system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above con...

Embodiment 2

[0039] Instruments and Conditions:

[0040] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0041] Chromatographic column: AD-H (Chiralpak, 250×4.6mm, 5μm);

[0042] Mobile phase: n-hexane: ethanol: methanol: diethylamine=96:2:2:0.2

[0043] Detection wavelength: 270nm

[0044] Flow rate: 1.2ml / min

[0045] Column temperature: 35°C

[0046] Injection volume: 20μl

[0047] Experimental steps:

[0048] Take about 10 mg of bortezomib, bortezomib enantiomer, diastereoisomer A and diastereoisomer B respectively, put them in 10ml measuring bottles, add about 0.3ml of methanol for ultrasonic treatment to dissolve, add flow Dilute to the mark, shake well, take the above solutions and mix them in equal amounts as the system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above conditi...

Embodiment 3

[0051] Instruments and Conditions:

[0052] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0053] Chromatographic column: AD-H (Chiralpak, 250×4.6mm, 5μm);

[0054] Mobile phase: n-hexane: ethanol: methanol: diethylamine=97:1.5:1.5:0.2

[0055] Detection wavelength: 270nm

[0056] Flow rate: 1.2ml / min

[0057] Column temperature: 35°C

[0058] Injection volume: 20μl

[0059] Experimental steps:

[0060] Take about 10 mg of bortezomib, bortezomib enantiomer, diastereoisomer A and diastereoisomer B respectively, put them in 10ml measuring bottles, add about 0.3ml of methanol for ultrasonic treatment to dissolve, add flow Dilute to the mark, shake well, take the above solutions and mix them in equal amounts as the system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above condi...

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Abstract

The invention discloses a method for detecting the content of optical isomers of bortezomib. The method is a high-performance liquid chromatography and comprises the steps as follows: a normal-phase chromatographic column with an amylase tris(3,5-dimethylphen-ylcarbamate) chiral stationary phase serving as a filler is adopted for coating the surface of silica gel, a mixed solvent of n-hexane, alcohol and an organic amine polarity modifier serves as a mobile phase, wherein the volume ratio of the n-hexane, the alcohol and the organic amine polarity modifier is (97-95):(3-5):(0-0.5), an ultraviolet detector is used for detection, the flow velocity is in a range of 1.0-1.4ml / min, and the temperature of the chromatographic column is in a range of 25-45 DEG C. According to the method, four optical isomers of the bortezomib can be well separated, so that the content of each optical isomer in the bortezomib can be measured accurately. The method is stable, reliable, high in sensitivity and applicable to quality control of bortezomib active ingredients and preparations of the bortezomib active ingredients in the research and production processes.

Description

technical field [0001] The invention relates to a method for detecting the content of bortezomib optical isomers, belonging to the field of drug analysis. Background technique [0002] Bortezomib (bortezomib) is a new type of anti-tumor drug developed by Millennium Corporation of the United States, and its trade name is Velcade. It is the first proteasome inhibitor to enter clinical application. Both the U.S. Food and Drug Administration and the European Agency for Drug Evaluation have approved Velcade for the clinical treatment of multiple myeloma. [0003] Bortezomib reversibly inhibits the chymotrypsin / trypsin activity of protease 26S subunit in mammalian cells by selectively binding to threonine in the proteasome active site, thereby inhibiting the expression of genes related to cell proliferation, Reduce the secretion of myeloma cell growth factors and the expression of adhesion factors, eventually leading to tumor cell apoptosis. Clinical studies have confirmed that ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈再新李小兵王勇军朱峰黄静王宋方英周慧琴陈建龙庄静静
Owner CHANGZHOU YABANG PHARMA
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