METHOD OF DETERMINATION OF COMPONENTS AND RELATED IMPURITIES OF CAPREOMYCIN Russian patent published in 2023 - IPC G01N30/02 G01N30/06 G01N30/32 G01N30/74 G01N33/15 

FIELD: pharmacy; chemistry; medicine.

SUBSTANCE: invention relates to a method of determining capreomycin and its impurities. A method of determining capreomycin and its impurities using ultra-performance liquid chromatography (UPLC) is as follows: the following is used: solution 1 with a pH of 9.8 at a concentration of 50 mm, which is a mixture of a solution of capreomycin 2 mg/ml and an aqueous solution of ammonia 32% in a ratio of 1,000:3.23, and solution 2 with pH 1.4 and a concentration of 50 mM, which is a mixture of a solution of capreomycin 2 mg/ml and trifluoroacetic acid in a ratio of 1,000: 3.83, solution 1 and solution 2 are combined in a ratio of 1:1 and diluted five times, filtered, chromatographed with a two-phase gradient elution with a flow rate of 0.1 ml/min to a temperature of 70°C, and then the flow rate of the two-component mobile phase is increased to 0.2 ml/min at a temperature of 70°C using a two-component mobile phase consisting of phase A, which is a composition of a buffer solution of pH 2.3 and acetonitrile in a ratio of 95:5, and phase B, which is a composition of a buffer solution of pH 2.3 and acetonitrile in a volume ratio 90:10, where the buffer solution for phases A and B is a solution consisting of a solution of sodium dihydrogen phosphate and a solution of sodium hexanesulfonate, adjusted with concentrated phosphoric acid, the detector wavelength is 268 nm, solution 1 and solution 2 are kept at 80°C within 24 hours.

EFFECT: above method is characterized by sensitivity and accuracy and allows to determine capreomycin and its impurities.

1 cl, 10 dwg, 3 tbl, 4 ex