Abstract
OBJECTIVE:To establish a sensitve HPLC method for the determination of loratadine in plasma and to evaluate its bioavailability.METHODS:A HPLC system consisted of a μBondapak C18 column and a mobile phase of methanol-acetone-0.01mol·L-1 phosphate buffer (pH7.5)(35∶35∶30).The detector was set to 275nm.Naphthozoline hydrochloride was selected as an internal standard.A crossover relative bioavilability study for two loratadine tablets was carried out in 12 healthy volunteers.RESULTS:The HPLC method had a linearity over the range of 0.2～30ng·ml-1.The limit of quantity was 0.1ng·ml-1.The average recoveries varied from 97.39%～103.96%.The results showed that AUC,cmax,tmax and t1/2β of two formulations had no significant difference (P>0.05).Relative bioavailability was (105.60±20.76)% (n=12).CONCLUSION:Two formulations of loratadine were bioequivalent.
Key words
loratadine /
bioavailability /
HPLC
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Jing Zhiqing.
Determination of loratadine in human plasma by a sensitive HPLC method and evaluation of its bioavailability[J]. Chinese Pharmaceutical Journal, 1999, 34(11): 757-759
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