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Determination of Manidipine in Human Plasma by UPLC–MS/MS and its Application to a Bioequivalence Study

[ Vol. 12 , Issue. 2 ]

Author(s):

Nguyen Lan Huong, Nguyen Huu Hoang, Sung-Yong Hong and Je Won Park   Pages 152 - 156 ( 5 )

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; Tmax, Cmax, and AUC0-12 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.

Keywords:

Manidipine, 96-well solid-phase extraction plate, liquid chromatography, mass spectrometry, bioequivalence study.

Affiliation:

School of Biosystem and Biomedical Science, Korea University, Anam-ro 145, Seoul 136-713, Republic of Korea.

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