A rapid detection method for residual organic solvents in pharmaceuticals

Abstract

The present application relates to the technical field of drug quality detection, and particularly relates to a rapid detection method for organic solvent residues in drugs. By collecting organic solvent residue parameter information of target drugs in a historical period, a comprehensive score benchmark containing the types and concentration weighted fusion is determined; based on the comprehensive score and statistical determination, the stability risk of a gas chromatography device is determined; if there is a risk, the first and second heating rates of the chromatography effluent are extracted, and the effectiveness of the chromatography effluent of the target drug is determined in combination with the peak shape index output by the hydrogen flame ionization detector; the heating rate direction and value are adjusted respectively for different peak shape abnormalities. The present application realizes active monitoring of device stability and self-adaptive correction of the heating rate, and overcomes the problem of low detection accuracy of organic solvent residues in drugs.

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