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 for quantitative determination of Angipur drug 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; and emission wavelength 340 nm. The method sensitivity (detection limit) for Angipur was 2.5 ng/mL; limit of quantitation, 5 ng/mL. The average measurement error was ≤ 15%.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 2, pp. 60 – 64, February, 2021.
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Smirnova, L.A., Ryabukha, A.F., Abramov, O.K. et al. Quantitative Determination of Angipur Drug Substance in Blood Plasma by HPLC with Fluorescence Detection. Pharm Chem J 55, 202–205 (2021). https://doi.org/10.1007/s11094-021-02381-5
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DOI: https://doi.org/10.1007/s11094-021-02381-5