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KMID : 0369820090390010073
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 1 p.73 ~ p.78
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Validation of LC-MS/MS Method for Determination of Rabeprazole in Human Plasma: Application of Pharmacokinetics Study
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Tak Sung-Kwon
Lee Kyung-Tae
Seo Ji-Hyung
Ryu Ju-Hee
Lee Myung-Jae
Choi Sang-Jun
Lee Jin-Sung
Kang Jong-Min
Yim Sung-Vin
Hong Seung-Jae
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Abstract
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A simple LC-MS/MS method of rabeprazole in human plasma was developed and validated. Rabeprazole and Internal standard (I.S), omeprazole, were extracted from human plasma by liquid liquid extraction, chromatographic separation of rabaprazole in plasma was achieved at with a Shiseido UG120 column and methanol-10 mM ammonium acetate buffer (pH 9.42 with ammonium water), as mobile phase. Rabeprazole produced a protonated precursor ion [] at m/z 360.10 and corresponding product ion at m/z 242.21. Internal standard produced a protonated precursor ion [] at 346.09 and corresponding product ion at m/z 198.09. This method showed linear response over the concentration range of with correalation coefficient greater than 0.99. The lower limit of quantitation (LLOQ) using 0.2 mL plasma was 1 ng/mL, which was sensitive enough for pharmacokinetics studies. The method was specific and validated with a limit of quantitation of 1 ng/mL. The intra-day and inter-day precision and accuracy were acceptable for all samples including the LLOQ. The applicability of the method was demonstrated by analysis of plasma after administration of a single 10 mg dose to 36 healthy subject. From the plasma rabeprazole concentration versus time curves, the mean (The area under the plasma concentration-time curve from time 0 to 12 hr ) was , (maximum plasma drug concentration) of reached after adiministration. The mean biological half-life of rabeprazole was . Based on the results, this simple method could readily be used in pharmacokinetics studies.
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KEYWORD
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Rabeprazole, Bioavailability, Validation, LC-MS/MS
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