Abstract\nBackground: Development of simple, rapid, and sensitive assay for the determination of loratadine\nin order to investigate its pharmacokinetic parameters in human plasma and its application in\nbioequivalence study of Loratadine 10mg Oral Disintegrated Tablets manufactured locally (test) and\noriginally (Reference).\nMethods: After extraction of loratadine from human plasma, it was chromatographed with mobile\nphase consisting of 0.5% formic acid: Acetonitrile (10:90 V/V) at flow rate 0.6ml/min, ESI positive mode,\nand m/z 383?337 for Loratadine. The bioequivalence study was conducted in a Two-Way Open-Label,\nCrossover design involving 24 volunteers. The criteria used to assess bioequivalence of the two products\nwere AUC0-t, AUC0-inf, Cmax, and Tmax.\nResults: the described method of analysis showed that the average recovery of Loratadine from human\nplasma was 102.685%. The limit of Quantitation was 0.05ng/ml, and the correlation coefficient (r2) was\nequal to 0.999893.\nStatistical analysis (ANOVA) of the measured parameters showed that there was no significant difference\nbetween the two products.\nConclusion: The LC/MS/MS method presented is direct, simple, reproducible, sensitive, and linear\nfor the determination of Loratadine in human plasma, and is adequate for clinical pharmacokinetic\nstudies, besides the test product was found to be bioequivalent to the reference and both products can be\nconsidered interchangeable in medical practice.
Loading....