Um So Young, Jung Sung Hee, Jung Seo Jeong, Kim Joo Il, Chung Soo Youn, Lee Hwa Jeong, Han Sang Beom, Choi Sun Ok
Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration, Nokbun-dong 5, Eunpyung-Ku, Seoul, Republic of Korea.
J Pharm Biomed Anal. 2006 Jun 16;41(4):1458-62. doi: 10.1016/j.jpba.2006.03.021. Epub 2006 May 8.
A column-switching high-performance liquid chromatographic (HPLC) method has been developed and validated for quantification of fluvastatin in rat plasma. Plasma samples were diluted with an equal volume of mobile phase, i.e. acetonitrile-5 mM potassium phosphate buffer (pH 6.8) (15:85, v/v), and the mixture was directly injected onto the HPLC system. The analyte was enriched in a pre-treatment column, while endogenous components were eluted to waste. The analyte was then back-flushed onto an analytical column and quantified with fluorescence detection (lambdaex=305 nm; lambdaem=390 nm). The standard curve for the drug was linear in the range 0.5-100 ng mL(-1) in rat plasma. The limit of quantitation for plasma was found to be 0.5 ng mL(-1). This method has been fully validated and shown to be specific, accurate and precise. The method is simple and rapid because of a minimized sample preparation and appears to be useful for the pharmacokinetic study of fluvastatin.
已开发并验证了一种柱切换高效液相色谱（HPLC）法，用于定量测定大鼠血浆中的氟伐他汀。血浆样品用等体积的流动相稀释，即乙腈-5 mM磷酸钾缓冲液（pH 6.8）（15:85，v/v），然后将混合物直接注入HPLC系统。分析物在预处理柱中富集，而内源性成分则被洗脱至废液中。然后将分析物反冲至分析柱上，并用荧光检测（激发波长=305 nm；发射波长=390 nm）进行定量。该药物在大鼠血浆中的标准曲线在0.5-100 ng mL(-1)范围内呈线性。血浆的定量限为0.5 ng mL(-1)。该方法已得到充分验证，结果表明具有特异性、准确性和精密度。由于样品制备过程简单，该方法简便快速，似乎可用于氟伐他汀的药代动力学研究。
