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- Title
Determination of Levocetirizine in Human Plasma by LC–MS-MS: Validation and Application in a Pharmacokinetic Study.
- Authors
Wichitnithad, Wisut; Jithavech, Ponsiree; Sanphanya, Kingkan; Vicheantawatchai, Petploy; Rojsitthisak, Pornchai
- Abstract
A fast and simple sample cleanup approach for levocetirizine in human was developed using protein precipitation coupled with LC–MS-MS. Samples were treated with 6% trichloroacetic acid in water prior to LC–MS-MS analysis. Chromatographic separation was performed on a reverse phase column with an isocratic mobile phase of acetonitrile and 10 mM ammonium formate pH 3.5 (80:20, v/v) at a flow rate of 1.0 mL/min. The run timewas 3.5 min. Mass parameters were optimized to monitor transitions at m/z [M+H]+ 389.0→201.0 for levocetirizine and m/z [M+H]+ 375.3→201.0 for hydroxyzine as internal standard. The lower limit of quantification and the dynamic range were 1.00 and 1.00–500 ng/mL, respectively. Linearity was good for intraday and interday validations (r² ≥ 0.995). The mean recoverieswere 59 and 69% for levocetirizine and hydroxyzine, respectively. Matrix effect was acceptable with %CV < 15. Hemolytic effect was negligible. Levocetirizine was stable in human plasma for 27 h at room temperature (25°C), for 16 weeks frozen at -70°C, 4 weeks frozen at -20°C, for 24 h in an autosampler at 15°C and for three freeze/thaw cycles. The validated method was applied in a pharmacokinetic study to determine the concentration of levocetirizine in plasma samples. The study provides a fast and simple bioanalytical method for routine analysis and may be particularly useful for bioequivalence studies.
- Subjects
PHARMACOKINETICS; HYDROXYZINE (Drug); ACETONITRILE; HIGH temperature plasmas; THERAPEUTIC equivalency in drugs
- Publication
Journal of Chromatographic Science, 2015, Vol 53, Issue 10, p1663
- ISSN
0021-9665
- Publication type
Article
- DOI
10.1093/chromsci/bmv069