Method devolpment and validation of desloratadine in bulk and its tablet dosage forms


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Volume :

1

Issue :

3

Abstract :

A simple and selective LC method is described for the determination of Desloratadine pharmaceutical dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase of a mixture of phosphate buffer, acetonitrile and methanol (50:40:10) with detection of 247 nm. Linearity was observed in the range 20-100 μg/ml (r2 =0.998) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability, inter-day, intra-day analysis, showing %RSD less than 2. The results did not show any statistical difference between operators suggesting that methods developed were rugged. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical formulation.
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