Ultra-performance liquid chromatography/tandem mass spectrometry method for the determination of lercanidipine in human plasma.
A simple, sensitive and rapid ultra-performance liquid chromatography/positive electrospray ionization tandem mass spectrometry (UPLC/ESI-MS/MS) method has been developed and validated for the determination of lercanidipine in human plasma. Lercanidipine and the internal standard, nicardipine, were extracted from plasma by liquid-liquid extraction using tert-butyl methyl ether as the extraction solvent. UPLC analysis was performed isocratically on an AcQuity UPLC BEH C18 analytical column (2.1 x 50.0 mm i.d., particle size 1.7 microm). The mobile phase consisted of 70% acetonitrile in water containing 0.2% v/v formic acid and pumped at a flow rate of 0.30 mL/min. ESI in positive ion mode, with multiple reaction monitoring (MRM), was chosen for the detection of the analytes. The assay was linear over a concentration range of 0.05-30 ng/mL for lercanidipine with a limit of quantitation of 0.05 ng/mL. Quality control samples (0.05, 0.15, 15 and 25 ng/mL) in five replicates from five of analytical runs demonstrated intra-assay precision (% CV < or =7.3%), inter-assay precision (% CV < or =6.1%) and an overall accuracy (% relative error) of less than 6.2%. A run time of less than 1.0 min for each sample made it possible to analyze a large number of human plasma samples per day. The method can be used to quantify lercanidipine in human plasma covering a variety of pharmacokinetic or bioequivalence studies.
Kalovidouris
Madgalene
M
University of Athens, School of Pharmacy, Division of Pharmaceutical Chemistry, Panepistimiopolis, Zografou 157 71, Athens, Greece.
Michalea
Stavroula
S
Robola
Nikoleta
N
Koutsopoulou
Maria
M
Panderi
Irene
I
D002121:Calcium Channel Blockers / Q000097:blood*; D002851:Chromatography, High Pressure Liquid; D004095:Dihydropyridines / Q000097:blood*; D006801:Humans; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*
D002121:Calcium Channel Blockers; D004095:Dihydropyridines; C060343:lercanidipine