摘要
目的建立血浆中氟伐他汀钠的含量测定方法,并用此法研究氟伐他汀钠在Beagle犬体内的药动学。方法血浆样品, 加同体积KH2PO4缓冲液(pH 2),乙醚提取,采用DiamonsilTM C18(4,6 mm×200 mm,5 μm)色谱柱,以甲醇-10 mmol·L-1 KH2PO4 (用H3PO4调pH2)(75:25)为流动相,流速1.0 mL·min-1,荧光检测(λex=305 nm,λem=390 nm)。所得数据用3P87药动学程序处理,求出有关的药动学参数。结果氟伐他汀在20.16～5 040.0μg·L-1内线性关系良好(r=0.999 8),最低检测限为5.04 μg·L-1(S/N=3)。高、中、低3个质控样品的平均方法回收率为93.30％～102.9％,提取回收率大于90％,日内、日间精密度的 RSD均小于5％。结论本法简便、灵敏、重现性好,可用于氟伐他汀钠的血药浓度分析及药动学研究。
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.
关键词
氟伐他汀 /
高效液相色谱法 /
药动学
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Key words
fluvastatin /
HPLC /
pharmacokinetics
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何敏;王向军;姚彤炜.
血浆中氟伐他汀测定方法的研究及其应用[J]. 中国药学杂志, 2006, 41(02): 132-134
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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脚注
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