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Validation of an HPLC Method for Determination of Pentoxifylline in Human Plasma and Its Application to Pharmacokinetic Study

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Abstract:

An HPLC method suitable for routine determination of pentoxifylline in human plasma has been adapted and validated. Sample preparation was done by solid-phase extraction. Chloramphenicol was used as the internal standard. The linear range was from 15400 ng/mL (r 2 = 0.9994), with a limit of quantitation of 15 ng/mL. The limit of detection was found to be 5 ng/mL. The intra- and interday accuracy ranged from 98.0 to 110.2 and the coefficient of variation was not more than 8.8 for both intra- and interday precision. The absolute recoveries of pentoxifylline and chloramphenicol from human plasma were >97. The method was validated with excellent specificity, accuracy, precision, recovery, and stability. The pharmacokinetic study of a generic pentoxifylline 400 mg tablet in healthy Thai male volunteers after a single dose administration was determined by this developed assay.

Document Type: Research Article

Affiliations: 1: Naresuan University, Faculty of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry and Pharmacognosy, Phitsanulok 65000, Thailand; Naresuan University, Faculty of Pharmaceutical Sciences, Bioequivalent Test Center, Phitsanulok 65000, Thailand. 2: Naresuan University, Faculty of Pharmaceutical Sciences, Department of Pharmaceutical Technology, Phitsanulok 65000, Thailand.

Publication date: 2009-05-28

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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