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Method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by GC-MS/MS method

A technology of gemcitabine hydrochloride and mesylate, applied in the field of drug analysis, to achieve the effects of strong specificity, wide linear range and high sensitivity

Active Publication Date: 2020-09-25
江西省药品检验检测研究院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows us to accurately determine how much certain chemical compounds have been found to cause harm or even death during medical treatments on cancer patients. By analyzing these samples from their sources, we aim to identify any potential health hazards associated therewith.

Problems solved by technology

This patent discusses the problem associated with identifying harmful compounds called metastable endocrins (METAs) during medicinal chemistry processes where they pose health concerns worldwide. Current methods involve analyzing large amounts of these potentially dangerous components through mass spectrometry techniques like liquidchromatography and gas chromatography. However, current analysis tools cannot accurately determine if certain compound(s) exist within limits set by international agreements stating safety standards proposed beforehand.

Method used

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  • Method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by GC-MS/MS method
  • Method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by GC-MS/MS method
  • Method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by GC-MS/MS method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] 1 Instruments and reagents

[0056] Agilent 7890B-7000C Gas Chromatograph-Tandem Mass Spectrometer

[0057] Dichloroethane source: TCI (Shanghai) Chemical Industry Development Co., Ltd.; batch number: P1529190;

[0058] Ethyl acetate source: LiChrosolv; Lot number: 10942649812; Purity: MS grade

[0059] Anhydrous sodium sulfate: Xilong Science Co., Ltd.; batch number: 1801051; content ≥ 99.0%; purity: analytically pure

[0060] Reference substance source

[0061] Methyl methanesulfonate source: SIGMA-ALORICH; batch number: MKCG1346; content: >99%

[0062] Source of ethyl methanesulfonate: SIGMA-ALORICH; Batch number: BCBW8635;

[0063] Isopropyl mesylate source: Thermo Fisher Scientific (China) Co., Ltd.; batch number: A031422; content: >98.0%

[0064] Propyl mesylate source: TCI (Shanghai) Chemical Industry Development Co., Ltd.; batch number: G6G6L-OM; content: >99%

[0065] Butyl mesylate source: Beijing Bailingwei Technology Co., Ltd.; batch number: LS20S35; c...

Embodiment 2

[0127] According to the preparation method of the test solution provided in Example 1, the quality of the gemcitabine hydrochloride crude drug was changed to 1.1 g, and the rest remained unchanged, and its methodological data could reach the effect of Example 1.

Embodiment 3

[0129] According to the preparation method of the test solution provided in Example 1, the quality of the gemcitabine hydrochloride bulk drug was changed to 1.3 g, and the rest remained unchanged, and its methodological data could reach the effect of Example 1.

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Abstract

The invention relates to the technical field of drug analysis, and particularly relates to a method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by a GC-MS/MS method. The method comprises the following steps of 1) adding 1, 2-dichloroethane into gemcitabine hydrochloride, performing ultrasonic treatment, adding 1, 2-dichloroethane to a constant volume to obtainan extracting solution, and filtering the extracting solution to obtain a test solution,2) determining the test solution in the step 1) by adopting a GC-MS/MS method, and calculating the content of each methanesulfonate genotoxic impurity in gemcitabine hydrochloride by adopting an external standard method, wherein the used gas chromatographic column is a VF-624ms chromatographic column, and the methanesulfonate genotoxic impurities comprise methyl methanesulfonate, ethyl methanesulfonate, isopropyl methanesulfonate, propyl methanesulfonate and butyl methanesulfonate. The determination methodprovided by the invention has the characteristics of strong impurity interference resistance, low noise, strong specificity and high sensitivity.

Description

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Claims

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Application Information

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Owner 江西省药品检验检测研究院
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