Quantitative Determination of Angipur Drug Substance in Blood Plasma by HPLC with Fluorescence Detection

A quantitative determination method using HPLC with fluorescence detection for the xanthine derivative 3-methyl-8-(piperazin-1-yl)-7-(thietan-3-yl)-1-ethyl-1H-purine-2,6(3H,7H)-dione hydrochloride (Angipur drug substance) in donor blood plasma was developed and validated. The optimal conditions of Angipur substance were KH2PO4 buffer (50 mM, pH 6.5); aqueous-to-organic phase ratio 55:45 v/v; added sodium heptanesulfonate modifier (0.15%); temperature 40°C; detector extinction wavelength 290 nm; emission 340 nm. sensitivity (detection limit) 2.5 ng/mL; limit quantitation, 5 ng/mL. average measurement error ? 15%.