Method for determining methyl p-toluenesulfonate in medicine

A technology of methyl toluenesulfonate and medicine, which is applied in the field of methyl p-toluenesulfonate content, can solve problems such as difficult to achieve accurate measurement, thermal instability, decomposition, etc.

Inactive Publication Date: 2018-01-26
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Methyl p-toluenesulfonate is easily hydrolyzed in the water phase environment, and has the characteristics of thermal instability, which is easy to decompose during the detection process
In addition, under the condition of the coexistence of drug substrates, there will also be the phenomenon of online generation of methyl p-toluenesulfonate
Due to the chemical activity of methyl p-toluenesulfonate, which is easily decomposed and generated online, it is not easy to achieve accurate determination of methyl p-toluenesulfonate in drugs

Method used

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  • Method for determining methyl p-toluenesulfonate in medicine
  • Method for determining methyl p-toluenesulfonate in medicine
  • Method for determining methyl p-toluenesulfonate in medicine

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Embodiment

[0031] Determination of methyl p-toluenesulfonate content in artemisinin analogues

[0032] 1. Chromatographic conditions

[0033] Instruments: Agilent 7890B Gas Chromatograph - 5977A Mass Spectrometer - 7697A Headspace Sampler

[0034] Chromatographic column: DB-Waxetr (30m×0.32mm×0.50μm)

[0035] Injection port temperature: 200°C

[0036] Injection volume: 1000μL

[0037] Split ratio: 50:1

[0038] Carrier gas: helium (constant flow 2.0mL / min)

[0039] Headspace conditions: Equilibrium temperature 70°C, quantitative loop temperature 90°C, transfer line temperature 130°C, equilibration time 30min.

[0040] Column temperature: keep at 40°C for 1min, raise the temperature to 100°C at 10°C / min, then raise the temperature to 220°C at 30°C / min, and keep for 3min.

[0041] Detector: mass spectrometer detector, ion source temperature 230°C, transfer line temperature 250°C.

[0042] SIM mode (127, 142): m / z 127 is used as an auxiliary qualifier ion, and m / z 142 is used as a qu...

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Abstract

The invention relates to a method for determining the content of methyl p-toluenesulfonate in a medicine, and concretely relates to a method for detecting the content of methyl p-toluenesulfonate in amedicine through headspace derivatization gas chromatography-mass spectrometry. The above derivatization method, using a mixed aqueous solution containing vitamin C and sodium iodide as a derivatization solution, has the advantages of wide suitable equilibrium temperature and equilibrium time range, high sensitivity, high precision, high accuracy, good durability, and easiness in operation, and can realize the accurate determination of the methyl p-toluenesulfonate in the medicine in order to ensure the safety of the medicine.

Description

technical field [0001] The invention belongs to the field of medicine analysis, and in particular relates to a method for measuring the content of methyl p-toluenesulfonate in medicine by headspace derivatization gas chromatography-mass spectrometry. Background technique [0002] A genotoxic impurity is a DNA-reactive substance capable of causing DNA damage that causes mutations and has the potential to be carcinogenic in humans. From the perspective of dosing cycle and toxicological safety, special attention should be paid to genotoxic impurities. [0003] Sulfonate is a potential genotoxic impurity. It usually comes from the side reaction of low molecular weight alcohol with sulfonic acid or sulfonic acid halide. It has various chemical structures, including mesylate such as methyl methanesulfonate, Ethyl, propyl, benzenesulfonate such as methyl benzenesulfonate, ethyl, propyl and p-toluenesulfonate such as methyl p-toluenesulfonate, ethyl and propyl, etc. [0004] Methy...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈东英刘雪薇张文鹏
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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