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KMID : 0369820070370040223
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 4 p.223 ~ p.227
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Validation of an LC/MS/MS Method for the Pharmacokinetic Study of Lercanidipine
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Kim Se-Mi
Yong Chul-Soon
Kang Hyun-Ah
Cho Hae-Young
Yoon Hwa
Kim Hwan-Ho
Lee Yong-Bok
Kim Yoon-Gyoon
Shin Sae-Byeok
Yang Chan-Woo
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Abstract
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rapid, simple and sensitive LC/MS/MS method for the determination of lercanidipine in human serum was validated and applied to the pharmacokinetic study of lercanidipine. Lercanidipine and internal standard, amlodipine, were extracted from human serum by liquid-liquid extraction with hexan-isoamyl alcohol (100: 1, v/v) and analyzed on a MS column with the mobile phase of acetonitrile-0.2% aqueous formic acid (70: 30, v/v). Using MS/MS with multiple reaction monitoring (MRM) mode, lercanidipine and amlodipine were detected without severe interferences from human serum matrix. Lercanidipine produced a protonated precursor ion () at m/z 612.3 and a corresponding product ion at m/z 280.0. Internal standard produced a protonated precursor ion (]) at m/z 409.0 and a corresponding product ion at m/z 238.0. The ruggedness of this method was investigated using quality control (QC) samples. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient greater than 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the developed method ranged from 85.51 to 112.2% for lercanidipine with overall precision (% C.V.) being 3.56-13.1%. This method showed good ruggedness (within 15% C.V.) and was successfully applied for the analysis of lercanidipine in human serum samples for the pharmacokinetic studies, demonstrating the suitability of the method.
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KEYWORD
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Lercanidipine, Human serum, Validation, Pharmacokinetics, LC/MS/MS
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