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- W2392255633 abstract "Objective: To establish an accurate and sensitive HPLC - MS method for the determination of loratadine in plasma and to evaluate its pharmacokinetic parameters and bioavailability in healthy Chinese male volunteers after a single oral dose of 20 mg loratadine test or reference tablets. Methods: A single oral dose of 20 mg loratadine test or reference tablets was given to 20 healthy Chinese male volunteers in a two - way cross - over design. The plasma sample were collected at predetermined time points after the administration. 1. 0 mL of each plasma sample was alkalized with 0. 1 mL of 0. 1 mol·L-1 sodium hydroxide solution and extracted with 5 mL ethyl acetate. The plasma concentrations of loratadine were determined by HPLC - MS method using Zorbax - Ext - ODS( 150 mm ×4. 6 mm,5 /m)column,methanol -acetonitrile -2.0% acetic acid solution(62:10:28)as mobile phase,with posi tive ion SIM detection of loratadine( [MH] + ,m/z =383)using diazepam( [ MH] + ,m/z =285) as the internal reference. Results:The limit of detection for loratadine was 0. 1 ng ·mL-1 and a good linearity was obtained in the range of 0. 2 -20 ng ·mL-1 (r =0. 9992) with the established HPLC - MS method. The extraction recovery was between 79. 3% - 84. 0%. The relative standard deviations of within - day and between - day determination were less than 15%. The main pharmacokinetic parameters after a single oral dose of 20 mg loratadine of the test and reference tablets were as follows:Cmax(ng·mL-1)8. 3±3.7 and 6. 8±5. 4,Tmax(h) 1. 3±0.6 and 1.3±0. 4,t1/2(h) 4. 6±1. 4 and 5.1±1.4, AUCO→∞( ng·h·mL-1)28. 4±21. 2 and 25. 6±16. 2, respectively; the relative bio availability(F) of the test to reference tablets was (112.9 ++?4.7)%. Conclusion:The established HPLC - MS method was shown to be sensitive, and accurate and the pharmacokinetic parameters determined were reliable. The statistic results shown that the test and reference tablets of loratadine were bioequivalent." @default.
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- W2392255633 date "2004-01-01" @default.
- W2392255633 modified "2023-09-25" @default.
- W2392255633 title "Study of Pharmacokinetics and Relative Bioavailability of Loratadine Tablets by HPLC -MS Method" @default.
- W2392255633 hasPublicationYear "2004" @default.
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