OBJECTIVE To establish a novel
HPLC-MS/MS method for the determination of trace
scutellarin and to investigate its
pharmacokinetics and bioequivalence of scutellarin in human body.METHODS After adding baicalin(internal standard,IS),the plasma samples were prepared with Waters
SPE cartridges and determined by HPLC-MS/MS.The separation was carried out on a ODS column(4.6 mm×250 mm,5 μm) at 35 ℃,with gradient elution,at a flow rate of 1.0 mL·min~(-1).HPLC-MS/MS was performed in the selected reaction monitoring(SRM) mode using target ions at m/z 463.0～287.0 for scutellarin and m/z 447.0～271.0 for baicalin(IS).A randomized crossover design was performed in 20 healthy volunteers.In the two study periods,a single
dose of 60 mg was administered to each volunteers.RESULTS The linear calibration curve was obtained in the concentration range of 0.2～20 μg·L~(-1)(r=0.999 5).The LOQ of scutellarin in plasma was 0.2 μg·L~(-1).The average recovery was more than 80%.The within and between-day variations(RSD) were less than 13%.The ρ_(max) of scutellarin in blood for the test and reference
formulations were(12.02±2.33) and(11.68±2.67)μg·L~(-1) at(5.9±0.8) and((5.6±1.6))h,respectively.The t_(1/2) were(2.27±0.58) and(2.25±0.44)h,respectively.The relative bioavailability of the test formulation was(104.2±13.0)%.CONCLUSION The method is proved to be special,sensitive,accurate and convenient.The pharmacokinetic profile of scutellarin in human after a single dose of 60 mg breviscapine ids discribed.The two formulations are bioequivalent.
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