A rapid and specific approach for direct measurement of donepezil concentration in human plasma by LC-MS/MS employing solid-phase extraction.
A selective, rapid and simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method is described for assay of donepezil in human plasma using escitalopram as an internal standard. Chromatographic separation was achieved on a Betabasic-C(8), 5 microm, 100 x 4.6 mm column using methanol:water:formic acid (90:9.97:0.03, v/v/v) as mobile phase. Detection of donepezil and internal standard was achieved by ESI MS/MS in positive ion mode using 380.20/91.10 and 325.13/262.00 transitions, respectively. The linearity over the concentration range of 0.15-50 ng/mL for donepezil was obtained and the lower limit of quantification was 0.15 ng/mL. For each level of quality control samples, inter-day and intra-day precisions (RSD) were < or =8.92 and 10.35% and accuracy (%RE) were < or =7.33% and 9.33%, respectively. The recovery was more than 88.50% for both donepezil and internal standard by solid-phase extraction, eliminating evaporation and reconstitution steps.
Shah
Hiten J
HJ
Bioanalytical Laboratory, Torrent Research Centre, Bhat, Gandhinagar-382428, Gujarat, India. hitenshah@torrentpharma.com
Kundlik
Mohan L
ML
Pandya
Ankit
A
Prajapati
Shivkumar
S
Subbaiah
Gunta
G
Patel
Chhagan N
CN
Patel
Dasharath M
DM
Suhagia
Bhanu N
BN
Suhagiya
Bhanu N
BN
D000328:Adult; D000925:Anticoagulants / Q000378:metabolism; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D002853:Chromatography, Liquid; D015283:Citalopram / Q000032:analysis; D000077265:Donepezil; D004355:Drug Stability; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D016014:Linear Models; D008297:Male; D010880:Piperidines / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D052616:Solid Phase Extraction; D021241:Spectrometry, Mass, Electrospray Ionization; D053719:Tandem Mass Spectrometry
D000925:Anticoagulants; D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D015283:Citalopram; D000077265:Donepezil