METHOD FOR QUANTITATIVE DETERMINATION OF PAPAVERINE HYDROCHLORIDE AND ITS RELATED IMPURITIES IN MEDICINES Russian patent published in 2022 - IPC G01N30/06 

FIELD: pharmaceutical industry.

SUBSTANCE: group of inventions relates to the field of pharmaceutical chemistry. Methods for the quantitative determination of papaverine hydrochloride and its related impurities in medicines are disclosed, including the preparation of solutions of a standard sample of papaverine hydrochloride at concentrations of 0.1 mg/ml and 0.004 mg/ml, the preparation of 2 mg/ml and 0.1 mg/ml solutions of test samples, while a mixture of acetonitrile and phosphate buffer solution pH 3.0 is used as a solvent in a ratio of 20:80, carrying out chromatography by HPLC 0.1 mg/ml and 0.004 mg/ml solutions of a standard sample of papaverine hydrochloride, 2 mg/ml of the test solution for the quantitative determination of related impurities and 0.1 mg/ml of the test sample solution for the quantitative determination of papaverine hydrochloride in the drug under gradient elution conditions, the quantitative content of papaverine hydrochloride and its related impurities is calculated by the external standard method.

EFFECT: group of inventions provides an increase in the accuracy of simultaneous quantitative determination of the basic substance and related impurities and a reduction in the time of sample preparation and testing.

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