Determination of Manidipine in Human Plasma by UPLC-MS/MS and its Application to a Bioequivalence Study
- Authors
- Nguyen Lan Huong; Nguyen Huu Hoang; Hong, Sung-Yong; Park, Je Won
- Issue Date
- 2016
- Publisher
- BENTHAM SCIENCE PUBL LTD
- Keywords
- Manidipine; 96-well solid-phase extraction plate; liquid chromatography; mass spectrometry; bioequivalence study
- Citation
- CURRENT PHARMACEUTICAL ANALYSIS, v.12, no.2, pp.152 - 156
- Indexed
- SCIE
SCOPUS
- Journal Title
- CURRENT PHARMACEUTICAL ANALYSIS
- Volume
- 12
- Number
- 2
- Start Page
- 152
- End Page
- 156
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/90176
- DOI
- 10.2174/1573412911999151012151244
- ISSN
- 1573-4129
- Abstract
- A rapid and highly sensitive method for the quantification of manidipine in human plasma was developed. Cleanup utilizing a 96-well solid-phase extraction technique is a simple and high-throughput method for extracting both manidipine and its internal standard felodipine from the quality-control samples: 97.5 +/- 2.1% for manidipine and 95.6 +/- 2.5% for IS. The ultra-performance liquid chromatography (UPLC) with tandem mass spectrometry (MS/MS) analytical tool, operated in a selective reaction monitoring mode was validated for manidipine quantification. The limit of detection and the lower limit of quantification were found to be 0.03 and 0.07 ng/mL, respectively. The intra-and inter-day precision was <3%, and accuracies ranged from 93.6 to 98.3%. A combination of the high-throughput SPE cleanup, and the sensitive and robust UPLC-MS/MS detection of manidipine at the picogram level was successfully applied to a bioequivalence study; T-max, C-max, and AUC(0-12) obtained from reference tablet were averaged at 2.26 h, 5.78 ng/mL, and 20.82 ng h/mL, whereas those from test one were at 2.31 h, 5.64 ng/mL, and 21.37 ng h/mL, respectively.
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Collections - College of Health Sciences > School of Biosystems and Biomedical Sciences > 1. Journal Articles
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