Method for detecting residual solvents of vildagliptin

By combining gas chromatography and an ECD detector with derivatization reagents, the problem of low sensitivity in the detection of chloroacetic acid residues in vildagliptin production was solved, achieving high sensitivity and good peak shape for the detection of chloroacetic acid residues, thus ensuring the quality control of vildagliptin.

CN116203176BActive Publication Date: 2025-11-11ZHEJIANG GUOBANG PHARMA
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Patent Information

Application Number
CN202310032135.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-01-10
Publication Date
2025-11-11
Estimated Expiration
2043-01-10

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Abstract

This application provides a method for detecting residual solvent in vildagliptin, belonging to the field of pharmaceutical analysis technology. The method uses an ECD detector, and quantitative analysis is performed after derivatizing the residual solvent chloroacetic acid in the vildagliptin sample with a derivatizing reagent. A DB-624 gas chromatographic column with cyanopropylbenzene-dimethylsiloxane as the stationary phase is used. This method quantitatively detects the residual amount of chloroacetic acid in vildagliptin, thereby effectively controlling the quality of vildagliptin. It has the advantages of being simple, highly specific, sensitive, accurate, reliable, and reproducible.
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