HPLC-MS를 이용한 생체시료 중 니세르골린의 주대사체인 10a-Methoxy-9,10-dihydrolysergol(MDL)의 분석 및이를 이용한 한국인 성인 남성에 대한 생체이용률 응용Determination of 10a-Methoxy-9,10-dihydrolysergol (MDL), Main Metabolite of Nicergoline, in Human Plasma by HPLC-MS and Applicability to Oral Bioavailability in Korean Healthy Male Volunteers
- Authors
- 임현균; 유선동; 김경호; 한상범; 염정록
- Issue Date
- 2007
- Publisher
- 대한약학회
- Keywords
- nicergoline; 10α-methoxy-9; 10-dihydrolysergol (MDL); bioavailability parameters; high performance liquidchromatography; mass spectrometry
- Citation
- 약 학 회 지, v.51, no.2, pp 133 - 139
- Pages
- 7
- Journal Title
- 약 학 회 지
- Volume
- 51
- Number
- 2
- Start Page
- 133
- End Page
- 139
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/30094
- ISSN
- 0377-9556
- Abstract
- A simple and sensitive HPLC-MS method for quantitation of 10α-methoxy-9,10-dihydrolysergol (MDL), the
main metabolite of nicergoline, in human plasma was developed and the bioavailability parameters of MDL was assessed
in Korean healthy male volunteers. Clomipramine was used as an internal standard. MDL and internal standard in plasma
sample were extracted using ethyl acetate. A centrifuged upper layer was then evaporated and reconstituted with mobile
phase of 10 mM ammonium acetate-acetonitrile (10 : 90, v/v). The reconstituted samples were injected into a Zorbax SBC8
column (2.1×150 mm, 5 µm) at a flow-rate of 0.3 ml/min. Using MS with selected ion monitoring (SIM) mode, MDL and
clomipramine were detected without severe interference from human plasma matrix. MDL produced a protonated molecular
ion ([M+H]+) at m/z 287. Internal standard produced a protonated molecular ion ([M+H]+) at m/z 315. A linear relationship
for MDL was found in the range of 2.5~100 ng/ml. The lower limit of quantitation (LLOQ) was 2.5 ng/ml with acceptable
precision and accuracy. The intra- and inter-day validation for all coefficients of variation (R.S.D.%) were found less than
15%. Main pharmacokinetic parameters of 30 mg of nicergoline were revealed as follows: AUCt 321.1±64.5 ng·hr/ml, Cmax
51.2±25.3 ng/ml, Tmax 3.6±1.5 hr, Kel 0.12±0.07 hr-1 and t1/2 7.6±3.4 hr. Inter subject variations and race differences were
shown in comparison with the published data in the literature.
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