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KMID : 0369820050350010051
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 1 p.51 ~ p.55
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Determination of Bumetanide in Human Plasma by a Validated HPLC Method and Its Application to Single-dose Pharmacokinetics
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박혜영/Park HY
곽혜선/전인구/Gwak HS/Chun IK
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Abstract
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A high-performance liquid chromatographic method was employed for the determination of bumetanide in human plasma. After addition of internal standard (IS, naproxen) and acidification of the plasma with 1 M hydrochloric acid, the drug and IS were extracted into dichloromethane. The organic phase was back-extracted into 1 M sodium bicarbonate solution and 50 ?l of the aqueous phase was injected onto a reversed-phase C18 column with a mobile phase consisting of methanol : water : glacial acetic acid = 65 : 35 : 1. The samples were detected utilizing a fluorescence detector (excitation wavelength 235 nm, emission wavelength 405 nm). The method was specific and validated with a lower limit of 5 ng/mL. Intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification. The applicability of the method was demonstrated by analysis of plasma after oral administration of a single 2 mg dose to 24 healthy subjects. From the plasma bumetanide concentration vs. time curves, the mean AUC was 246.5 ± 73.8 ng ? hr/mL and Cmax of 132.1 ± 40.9 ng/mL reached 1.2 hr after administration. The mean biological half-life of bumetanide was 1.1 ± 0.2 hr. Based on the results, this simple and validated assay method could readily be used in any pharmacokinetic or bioequivalence studies using humans.
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KEYWORD
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Bumetanide, HPLC, Fluorescence, Validation, Pharmacokinetics
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