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

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

Volume: 12 Issue: 2

Author(s): Nguyen Lan Huong, Nguyen Huu Hoang, Sung-Yong Hong and Je Won Park

Affiliation:

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

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.

Cite this article as:

Huong Lan Nguyen, Hoang Huu Nguyen, Hong Sung-Yong and Park Won Je, Determination of Manidipine in Human Plasma by UPLC–MS/MS and its Application to a Bioequivalence Study, Current Pharmaceutical Analysis 2016; 12 (2) . https://dx.doi.org/10.2174/1573412911999151012151244