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Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study

Dalmora, Sérgio Luiz et al · SEDICI UNLP · 2009

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Author / responsible party
Dalmora, Sérgio Luiz et al
Publisher
SEDICI UNLP
Year
2009
Language
English

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A sensitive and specific method based on liquid chromatography was developed and validated for the determination of phenytoin in human plasma using phenobarbital as internal standard. The drugs were extracted from plasma by liquid-liquid extraction and separated isocratically on a Phenomenex Synergi MAX-RP C<sub>12</sub> column (150x 4.6 mm i.d.), with water: acetonitrile: methanol(58.8:15.2:26, v/v/v) as mobile phase. Detection was carried out using photodiode array detector set at 205 nm. The chromatographic separation was obtained within 12 min and was linear in the concentration range of 50-2500 ng/mL (r2 = 0.9999). The method was successfully applied for the bioequivalence study of two tablet formulations (test and reference) of phenytoin 100 mg after single oral dose administration to 28 healthy human volunteers. The 90% confidence intervals were calculated for the C<sub>max</sub>, AUC<sub>(0-t)</sub> and AUC<sub>(0-∞)</sub>, giving values between 99.97–118.40% demonstrating the bioequivalence of the two formulations. Colegio de Farmacéuticos de la Provincia de Buenos Aires

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APA 7

Dalmora, S. L. E. A. (2009). Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study. https://nodovox.com/record.php?id=370369

MLA

Dalmora, Sérgio Luiz et al. "Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study." 2009. https://nodovox.com/record.php?id=370369.

Chicago

Dalmora, Sérgio Luiz et al. 2009. "Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study.". https://nodovox.com/record.php?id=370369.

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Dalmora, S. L. E. A. 2009, Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study, SEDICI UNLP, available at: https://nodovox.com/record.php?id=370369 [Accessed 9 Aug. 2026].

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Title
Determination of phenytoin in human plasma by a validated liquid chromatography method and its application to a bioequivalence study
Author / contributors
Dalmora, Sérgio Luiz et al
Publisher
SEDICI UNLP
Publication year
2009
Language
English

Subjects

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Farmacia; bioequivalence; liquid chromatography; liquid-liquid extraction; pharmacokinetics; phenytoin; Medicamento; Cromatografía líquida
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