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KMID : 0369820060360020089
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 2 p.89 ~ p.95
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Development and Validation of an HPLC Method for the Pharmacokinetic Study of Pentoxifylline in Human Serum
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조혜영/Cho HY
강현아/류희두/이화정/문재동/이용복/Kang HA/Yoo HD/Lee HJ/Moon JD/Lee YB
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Abstract
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A selective and sensitive reversed-phase HPLC method for the determination of pentoxifylline in human serum was developed, validated, and applied to the pharmacokinetic study of pentoxifylline. Pentoxifylline and internal standard, chloramphenicol, were extracted from the serum by liquid-liquid extraction with dichloromethane and analyzed on a Luna CI8(2) column with the mobile phase of acetonitrile-0.034 M phosphoric acid (25:75, v/v, adjusted to pH 4.0 with 10 M NaOH). Detection wavelength of 273 nm and flow rate of 0.8 mL/min were used. This method showed linear response over the concentration range of 10-500 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of the serum was 10 ng/mL, which was sensitive enough for pharmacokinetic studies of pentoxifylline. The overall accuracy of the quality control samples ranged from 89.3 to 92.7% for pentoxifylline with overall precision (% C.V.) being 4.1-9.2%. The relative mean recovery of pentoxifylline for human serum was 105.8%. Stability (stock solution, short and long-term) studies showed that pentoxifylline was not stable during storage. But three freeze-thaw cycles and extracted serum samples were stable. This method showed good ruggedness (within 15% C.V.) and was successfully applied for the analysis of pentoxifylline in human serum samples for the pharmacokinetic studies of orally administered Trental® tablet (400 mg pentoxifylline), demonstrating the suitability of the method.
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KEYWORD
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Pentoxifylline, Human serum, Validation, Pharmacokinetics, HPLC
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