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A MSALL quantitative method for the determination of Poloxamer 188 in rat plasma by UHPLC-Q-TOF/MS and its application to pharmacokinetic study.

Poloxamer (PL)188 is a commonly used pharmaceutical excipient with unique physicochemical properties. In this study, a MSALL quantitative method for the determination of PL188 in rat plasma by UHPLC-Q-TOF/MS was developed and validated. PL188 was analyzed on PLRP-S Reversed-Phase column (50 × 4.6 mm, 8 μm, 1000 Å) with mobile phase 0.1% formic acid-water and 0.1% formic acid-acetonitrile: isopropanol (2:3, v/v). The liner range was 0.1~10.0 μg/mL. Pharmacokinetic study was experimented on rats at a dose of 5 mg/kg by intravenous injection. The pharmacokinetic parameters of intravenous injection were as follows: t1/2 was 2.0 ± 1.1 h, Vd was 5.1± 3.2 L/kg, AUC(0-t) was 3.0 ± 0.6 μg/L*h, CL was 1.7 ± 0.3 L/h/kg. The results indicated that PL188 could be rapidly distributed to tissues with a high clearance rate. This study can provide a good reference for the further study of PL188.