TITLE:
Nonclinical Study of the Active Components of Doxorubicin Hydrochloride Liposome Injection in Vivo
AUTHORS:
Bing Wang, Wangning Zhang, Ping Wang, Qilin Zhou, Kaiyu Zhang, Jiaxin Zhang, Jiangwei Tian
KEYWORDS:
Doxorubicin Hydrochloride Liposomes, Pharmacokinetics, LC-MS/MS
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.14 No.9,
September
12,
2023
ABSTRACT: Objectives: A
non-clinical study was performed to establish a LC-MS/MS method to determine
the in vivo active components of
doxorubicin hydrochloride liposome injection in the plasma of Sprague-Dawley
rats. Methods: Ten male SD rats were administered tail vein with a
single dose of 10 mg/kg, and the concentrations of doxorubicin hydrochloride in
plasma, heart, liver, spleen, lung, and kidney were determined by liquid
chromatography-tandem mass spectrometry, and the pharmacokinetic parameters
were calculated. Results: The final concentration of doxorubicin
hydrochloride ranged from 500 ng/mL to 250,000
ng/mL, and the lower limit of quantification was 500 ng/mL; the main pharmacokinetic parameters: T1/2 was (19.282 ± 10.305) h, Cmax was (118514.828 ± 26155.134)
ng/mL, AUC0-24 and AUC0-∞ were (1216659.205 ± 192706.268)
ng/mL⋅h and (2082244.523 ± 860139.487) ng/mL⋅h, MRT0-24 and MRT0-∞ were (9.237 ± 0.423) h and (26.52 ± 14.015) h, respectively, and clearance (CL)
was (0.005 ± 0.002) mL/h⋅ng. Conclusions: The method is simple, rapid,
and sensitive, which can be used for the determination of doxorubicin
hydrochloride concentration in the plasma of SD rats and pharmacokinetic
non-clinical studies.