Method for detecting dimethyl sulfate and diethyl sulfate in brivaracetam and application thereof
The optimized detection of dimethyl sulfate and diethyl sulfate in briracetam by gas chromatography-tandem mass spectrometry (GC-MS/MS) solves the problems of insufficient sensitivity and specificity in the existing technology, and realizes efficient and accurate detection of trace impurities, ensuring the safety and quality control of briracetam.
Patent Information
- Application Number
- CN202610747156.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-05-28
- Publication Date
- 2026-07-17
AI Technical Summary
Existing gas chromatography-mass spectrometry (GC-MS) methods for detecting dimethyl sulfate and diethyl sulfate in bricetam suffer from insufficient sensitivity and specificity, making it difficult to meet the stringent control requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for trace impurities. In particular, they exhibit insufficient selectivity and low signal-to-noise ratio in complex matrices.
Gas chromatography-tandem mass spectrometry (GC-MS/MS) was employed, using a capillary column with a stationary phase of 6% cyanopropylphenyl-94% dimethylpolysiloxane. Specific ion pairs were monitored through multiple reaction monitoring mode. Combined with optimized GC conditions and mass spectrometry parameters, high sensitivity and high specificity were achieved for the detection of dimethyl sulfate and diethyl sulfate.
It achieves excellent specificity and anti-interference ability for dimethyl sulfate and diethyl sulfate in briracetam, with extremely high sensitivity and good accuracy. It has high detection efficiency and can achieve baseline separation and accurate quantification within 15 minutes of a single injection, meeting the trace control requirements for genotoxic impurities.
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Figure CN122409914A_ABST