A validated HPLC-ESI-MS method for the determination of loratadine in human plasma and its application to pharmacokinetic studies.
A liquid chromatographic-mass spectrometric (LC-MS) assay was developed and validated for the determination of loratadine in human plasma using reversed-phase HPLC combined with electrospray ionization (ESI) mass spectrometry. The analysis involved a simple liquid-liquid extraction. The organic extract was then evaporated and the residue was reconstituted in mobile phase. The reconstituted solution was injected into an HPLC system and was subjected to reverse-phase HPLC on a 5-microm ODS-3 column at a flow-rate of 0.2 ml/min. The mobile phase comprised of acetonitrile-ammonium acetate (pH 4.0; 0.02 M, using formic acid to adjust) using gradient elution. Loratadine was detected in the single ion monitoring (SIM) mode. Standard curves were linear over the concentration range of 0.2-100 ng/ml. The mean predicted concentrations of the quality control (QC) samples deviated by less than 10% from the corresponding nominal values; the intra-assay and inter-assay precision of the assay were within 12% relative standard deviation. The extraction recovery of loratadine was more than 80%. The validated assay was applied to a pharmacokinetic study of loratadine in human plasma following the administration of a single loratadine tablet (40 mg).
Chen
J
J
Department of Pharmaceutics, School of Pharmacy, Fudan University, Shanghai, P. R. China.
Zha
Y Z
YZ
Gao
K P
KP
Shi
Z Q
ZQ
Jiang
X G
XG
Jiang
W M
WM
Gao
X L
XL
D000293:Adolescent; D000328:Adult; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D006634:Histamine H1 Antagonists / Q000097:blood* / Q000493:pharmacokinetics*; D006801:Humans; D017336:Loratadine / Q000097:blood* / Q000493:pharmacokinetics*; D008297:Male; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D021241:Spectrometry, Mass, Electrospray Ionization
D006634:Histamine H1 Antagonists; D012996:Solutions; D017336:Loratadine