Bioequivalence study of Loratadine tabletes and capsules in healthy volunteers

OBJECTIVE To develop a column-switching HPLC method for determination of Loratadine in human plasma and to study the bioequivalence of Loratadine tabletes,capsules in 23 healthy volunteers.METHODS Single oral dose(40 mg) of Loratadine tabletes,capsules and comparison preparation Loratadine tabletes were given to 23 healthy male volunteers randomized three cross-over study.Loratadine concentration in plasma was determined by column-switching HPLC method.The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS The concentration-time curves bioavailability were conformed to an two-compartment open model.The main pharmacokinetic parameters of Loratadine tables,capsules and comparison preparation were as follows:AUC_(0-12) were 147.00±102.75,135.41±94.24,139.76±94.76 ng·ml~(-1)·h;C_(max) were 68.20±37.47,57.52±39.17,66.49±41.41 ng·ml~(-1);T_(max) were 0.78±0.22,0.98±(0.24,)0.98±0.37 h,respectively.The relative bioavailability of Loratadine tables and capsules were 110.0%±40.0%,98.0%±23.0%,(respectively.)CONCLUSION Statistical analysis showed that Loratadine tabletes,capsules,comparison preparation are bioequivalent.