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VALIDATION AND APPLICATION OF A NEW DAD-HPLC METHOD FOR DETERMINATION OF LORATADINE FROM PHARMACEUTICALS

GEORGETA PAVALACHE^1*, VASILE DORNEANU², ANTOANELA POPESCU¹

1.”Ovidius” University Constanta, Faculty of Pharmacy, Constanţa, Romania
² .”Gr. T. Popa” University, Faculty of Pharmacy, Iasi, Romania

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In our previous research, we developed a DAD-HPLC method for the quantitative determination of loratadine in different samples [1]. The proposed method was internally validated and its performance parameters were established: linearity, working range, selectivity, recovery test, accuracy and precision. Validation results showed a good accuracy of the method, the optimum repeatability and reproducibility. Bias for the accuracy of loratadine assay by HPLC is 100.20%, being in the recovery range of 95-105%, which shows that the method is accurate. The applicability of the method was verified by analysing samples from pharmaceutical products containing loratadine (Roletra® Tablets, Clarinase® modified-release Tablets and Symphoral® syrup).