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KMID : 0941820050150010046
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Korean Journal of Clinical Pharmacy
2005 Volume.15 No. 1 p.46 ~ p.49
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Validation of a HPLC Method for Determination of Pentoxifylline in Human Serum and Its Application to Single-dose Pharmacokinetics
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Sung Min-Kyung
Park Hyo-Min
Kim Na-Hyung
Chung Soo-Yeon
Go Eun-Jung
Lee Hwa-Jeong
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Abstract
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A simple HPLC method was employed for the determination of pentoxifylline in human serum. After addition of internal standard (IS, 50 uL of 3 ug/mL chloramphenicol methanol solution) into the serum sample, the drug and IS were extracted by dichloromethane. Following a 1-min vortex-mixing and a 15-min centrifugation at 3500 게m, the organic phase was transferred and evaporated to dryness under a vacuum. The residue was reconstituted with 120 {mu}L of mobile phase and 50 {mu}L was injected into C18 column with a mobile phase composed of 0.034 M phosphoric acid adjusted to pH 4 with 10 M NaOH and acetonitrile (75:25, v/v). The samples were detected using an ultraviolet detector at 273 nm. The method was simple, specific and validated with a limit of 10 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 this method was evaluated by analysis of human serum after oral administration of a single 400 mg dose to 8 healthy subjects. The pharmacokinetic parameters for pentoxifylline in human subjects were calculated using WinNonlin program. As a result, AUC_{t},;C_{max},;T_{max} and t_{1/2} were 962.28{pm}645.69;ng{cdot}/mL, 132.82{pm}42.05 ng/mL, 2.06{pm}2.68 hr and 8.74{pm}4.38 hr, respectively. Based on the results, this validated method appears to be useful fur the pharmnacokinetic study of pentoxifylline in humans.
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KEYWORD
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pentoxifylline, HPLC, validation, pharmacokinetics
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