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Method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in calcium dobesilate capsule

A technology of diisopropyl sulfate and calcium dobesilate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of DNA mutagenesis and damage, and achieve the effect of excellent evaluation index and simple operation of derivatization treatment

Pending Publication Date: 2022-03-01
贵州天安药业股份有限公司
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Problems solved by technology

[0002] According to the definition of ICH M7 "Guidelines for the Evaluation and Control of DNA Mutagenic Impurities in Drugs to Limit Potential Carcinogenic Risks", genotoxic impurities are substances with DNA reactivity, and these substances are at low levels. There is also a risk of causing DNA damage, leading to DNA mutagenesis, which can lead to cancer

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  • Method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in calcium dobesilate capsule
  • Method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in calcium dobesilate capsule
  • Method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in calcium dobesilate capsule

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Embodiment 1

[0027] Embodiment 1 of the present invention: The present invention is described below by examples, but the present invention is not limited thereto.

[0028] The methods used in the following examples are conventional methods unless otherwise specified; the reagents and materials used in the following implementations can be obtained from commercial sources unless otherwise specified.

[0029] 1. Instruments and reagents

[0030] Agilent 7890A-5975C gas chromatography-tandem mass spectrometer, Mettler Toledo XP205 electronic balance, Agilent DB-624UI chromatographic column, Shanghai Hetai Medium S800UVT ultrapure water instrument, Merck HPLC grade acetonitrile, MACKLIN 99% thiosulfuric acid pentahydrate Sodium, MACKLIN 99.5% sodium iodide, Aladdin diethyl sulfate 99.0%, TOKYO CHEMICAL INDUSTRY CO., LTD. Diisopropyl sulfate 97.0%.

[0031] Derivatization reagent preparation method: Weigh about 60g of sodium iodide and 50mg of sodium thiosulfate pentahydrate into a 100ml beaker...

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Abstract

The invention discloses a method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in a calcium dobesilate capsule by a GC-MS (Gas Chromatography-Mass Spectrometer) method. According to the method, diethyl sulfate and diisopropyl sulfate which are high in boiling point react with the derivatization reagent to generate iodoethane and iodoisopropane which are low in boiling point and easy to gasify, and the derivatization treatment operation of the method is simple; the content of genotoxic impurities of diethyl sulfate and diisopropyl sulfate in the calcium dobesilate capsule is indirectly measured through a GC-MS method, and compared with an HPLC method, the method has obvious advantages in sensitivity. The analysis methodology verification result of the method shows that the specificity, sensitivity, precision, accuracy and linearity of the method accord with the verification guidance principle of the correlation analysis method, and each evaluation index is excellent.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting genotoxic impurities of diethyl sulfate and diisopropyl sulfate in calcium dobesilate capsules. Background technique [0002] According to the definition of ICH M7 "Guidelines for the Evaluation and Control of DNA Mutagenic Impurities in Drugs to Limit Potential Carcinogenic Risks", genotoxic impurities are substances with DNA reactivity, and these substances are at low levels. There is also a risk of causing DNA damage, leading to DNA mutagenesis, which can lead to cancer. According to Derek / Sarah prediction results (ICHM7), ​​diethyl sulfate and diisopropyl sulfate show genotoxicity, of which diethyl sulfate is ICH M7 type 2 genotoxic impurity, diisopropyl sulfate is ICH M7 type 3 genotoxicity Impurities. [0003] Calcium dobesilate capsules are mainly used for the treatment of microvascular diseases; chronic venous insufficiency (varicose vein sy...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88
Inventor 肖斌鄢菊申基琛张凡
Owner 贵州天安药业股份有限公司
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