Abstract
OBJECTIVE To establish a HPLC method for the determination of fluvastatin sodium in plasma and to investigate its pharma-cokinetic characteristics in Beagle dogs.METHODS The plasma was mixed with the same volume of KH2PO4 buffer (pH 2) . Fluvastatin was extracted from plasma with ether. The content of fluvastatin in plasma was detected by fluorescence detector at λex 305 nm,λem 390 nm with the DiamonsilTM C18(4.6 mm×200 mm,5 μm)column. The mobile phase consisted of methol-10 mmol·L-1 KH2PO4(adjusted to pH2 with H3PO4) (75:25) at a flow rate of 1.0 mL·min-1. The data obtained was processed with 3P87 program for pharmacokinetic parameters.RESULTS The linear range was 20.16～5 040.0 μg·L-1(r=0.999 8). The lowest detectable concentration was 5.04 μg·L-1(S/N=3). The average method recovery was 93.30%～102.9% , and extracted recovery was over 90% for the low, middle, high control sample. The relative standard deviations obtained for inter-and intra-assay precisions were less than 5% .CONCLUSION This method is convenient, sensitive and reproducible, and is suitable for the determination of fluvastatin sodium concentration in plasma for pharmacokinetic studies.
Key words
fluvastatin /
HPLC /
pharmacokinetics
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HE Min;WNG Xing-jun;YO Tong-wei.
Determination of Fluvastatin Sodium in Plasma: Application to Pharmacokinetics [J]. Chinese Pharmaceutical Journal, 2006, 41(02): 132-134
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