Pharmacokinetics and bioequivalence of ondansetron extended-release capsule by HPLC-MS

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Pharmacokinetics and bioequivalence of ondansetron extended-release capsule by HPLC-MS[url=]Shen Yulan[/url],
[url=]Feng Qi[/url],
[url=]Sun Qi[/url]

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26 Nov 2010 1333-1336Language:chi
CBA: 644248

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Abstract

Pharmacokinetics and bioequivalence of ondansetron extended-release capsule by HPLC-MS[url=]Shen Yulan[/url],
[url=]Feng Qi[/url],
[url=]Sun Qi[/url]

26 Nov 2010 1333-1336Language:chi

CBA: 644248

To build a sensitive and specific LC-ESI-MS method for the determination of ondansetron in human plasma. The method was then applied successfully to the pharmacokinetic and bioequivalence study of an extended-release capsule of ondansetron. Mirtazapine was used as the internal standard. After adding mirtazapine, the plasma samples were extracted with ethyl acetate and determined by HPLC-MS, The separation was carried out on a Shimadzu VP-ODS column4. 6 mm 150 mm,5 #mu#m using a mobile phase consisting of methanol-acetonitrile 10 mmol · L~(-1) ammonium acetate 35 30 35 delivered at 1 mL · min~(-1). HPLC-MS was performed with the selected ion monitoring SIM mode using target ions at m/z 294. 5 for ondansetron and m/z 265.5 for mirtazapine, A randomized crossover design was performed in 20 healthy volunteers. The linear calibration curve was obtained in the concentration range of 0. 1-80 #mu#g · L^- 1 r = 0. 999 9 . The detection limit of ondansetron in plasma was 0. 1#mu#g · L~(-1). The average recovery was more than 85%, The relative bioavailability of the test formulation in single-dose and multipledose pharmacokinetic study were 94. 1 ±15.8% and 94. 8 ± 14. 3 %, respectively. The assay was proved to be sensitive, accurate and convenient. The results of statistic analysis showed that the test ondansetron extended-release capsule and the reference ondansetron tablet were bioequivalent, and the test capsule had the characteristics of extended-release formulation.

[Other] Pharmacokinetics and bioequivalence of ondansetron extended-release capsule by HPLC-MS

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