METHOD FOR QUANTITATIVE DETERMINATION OF AMINOCAPROIC ACID IN ITS SIMULTANEOUS PRESENCE WITH A COPOLYMER OF 2-METHYL-5-VINYLPYRIDINE AND N-VINYLPYRROLIDONE BY THE METHOD OF HPLC Russian patent published in 2019 - IPC G01N30/22 

FIELD: chemistry.

SUBSTANCE: invention relates to analytical chemistry and provides a method for quantitative determination of aminocaproic acid (ACA) when combined with copolymer of 2-methyl-5-vinylpyridine and N-vinylpyrrolidone (CP) in various ready dosage forms, such as, for example, nasal drops or sprays. That is ensured by preparing calibration solutions of ACA of pharmacopoeial quality with concentrations the values of which are at the limits of tolerable deviations, as well as in the area of impermissible deviations. Accumulation of ACA is carried out by reversed-phase HPLC in an ion-pair version on a column with length of 250 mm and an inner diameter of 4.6 mm, filled with a fixed phase formed by spherical particles of silicon dioxide with size of 5 mcm, modified octadecylsilane in a gradient mode, mobile phase A contains (1 % H₃PO₄+10 mmol PSNa+15 mmol K₂NRA₄ in H₂O): methanol in ratio of 70:30, and mobile phase B is methanol. ACA detection is carried out spectrophotometrically at wavelength of 210 nm and calculating arithmetic mean values of area under ACA curve (AUC) with subsequent approximation of linear function to AUC=kc_ACA to calculate coefficient k. Drug solution is diluted with mobile phase A to 0.5–5 mg/ml, chromatographed at least 3 times. After the samples are analyzed, a conclusion is made on the compliance of the preparation with the requirements for the content of ACA.

EFFECT: invention provides rapidness of analysis, as well as reduced labor and cost of quantitative determination of ACA.

1 cl, 5 dwg, 2 tbl, 2 ex