METHOD FOR DETERMINING THE AMOUNT OF DOXORUBICIN WHEN RELEASED FROM FUNCTIONALIZED CALCIUM PHOSPHATE CONSTRUCTS Russian patent published in 2020 - IPC G01N33/15 G01N30/00 

FIELD: technological processes.

SUBSTANCE: present invention relates to a group of laboratory methods used in the development of new pharmaceutical products (PP), novel methods of delivering PP, as well as when monitoring the quality of PP and their innovative forms. Disclosed is a method of determining the amount of doxorubicin when released from functionalised calcium phosphate constructs. Method includes highly efficient liquid chromatography with UV detection. To saturate the implant, a dosage form of doxorubicin is used, and the doxorubicin concentration when exiting from the implant is determined under the following conditions: volume of the sample introduced into chromatograph is 10 mcl, used as a mobile phase is a mixture of acetate buffer pH 4.5 and isopropyl alcohol in ratio of 70:30, flow rate of eluent 0.7 ml/min, temperature of temperature control column 37 °C, detection at analytical wavelength of 290 nm and reference wavelength of 360 nm.

EFFECT: high selectivity, wide linear range (25–500 mcg/ml), high sensitivity and low limit of quantitative determination (4 mcg/ml); absence of influence on determination of target substance (DOX-GC) of accompanying substances of organic matrix; use for functionalisation of CPK of the registered ready-for-use dosage form DOX-GC with excipients; no need for additional extraction of DOX-GC using toxic organic solvents; column temperature is 37 °C, which corresponds to the physiological conditions of DOX-GC presence in the body; low flow rate (0_7 ml/min) reduces consumption of reagents; volume of sample introduced into chromatograph is 10 mcl, id est sensitivity and precision of the method enables using considerably smaller sample volumes.

1 cl, 1 tbl, 1 ex, 3 dwg