title: Ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nitrendipine in dog plasma and its application to a pharmacokinetic study of a solid self-emulsifying pellet formulation.
abstract: A rapid, sensitive and selective ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the quantitative determination of nitrendipine (NTD, CAS 39562-70-4) in dog plasma. Using propranolol hydrochloride (CAS 318-98-9) as an internal standard (IS), plasma samples pretreatment adopted a simple liquid-liquid extraction process with diethyl ether. Separation was carried out by a gradient elution on an Acquity UPLC BEH C18 column with a mobile phase consisting of water (containing 0.1% formic acid) and acetonitrile. Detection was performed by a triple-quadrupole mass spectrometry with positive electrospray ionization (ESI) as source ionization in multiple-reaction monitoring (MRM) mode at m/z 361.0 --> 315.0 for NTD and m/z 260.2 --> 116.0 for IS. The method demonstrated good linearity at the concentrations ranged from 0.1-200 ng/mL and the lower limit of quantification (LLOQ) of NTD was 0.1 ng/mL. The intra- and inter-day relative standard deviations (RSD) were less than 10%. The mean extraction recoveries of NTD and IS were 90.2% and 82.4%, respectively. Finally, the method was successfully applied to a pharmacokinetic study of home-made solid self-emulsifying pellets and conventional NTD tablets in beagle dogs following a single oral administration.
authors.affiliation: Department of Biopharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, P.R. China. lyanhua1214@126.com
authors.forename: Yanhua
authors.initials: Y
authors.lastname: Liu
authors.forename: Zhiyuan
authors.initials: Z
authors.lastname: Wang
authors.forename: Jin
authors.initials: J
authors.lastname: Sun
authors.forename: Yongjun
authors.initials: Y
authors.lastname: Wang
authors.forename: Zhonggui
authors.initials: Z
authors.lastname: He
mesh_terms: D000284:Administration, Oral; D000818:Animals; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D004285:Dogs; D004655:Emulsions; D008297:Male; D009568:Nitrendipine / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D011786:Quality Control; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry
chemical_list: D002121:Calcium Channel Blockers; D004655:Emulsions; D009568:Nitrendipine