Abstract

METHOD DEVELOPMENT AND VALIDATION OF PSEUDOEPHEDRINE HCL AND LORATADINE BY RP-HPLC IN BULK AND TABLET DOSAGE FORM

*S. Asma, K.Venugopal, Sura, Ramya Sri, NV.Muralikrishna, PT.Nagaraju, R.Naganjaneyulu.

Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Pseudoephedrine Hcl and Loratadine in bulk and tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6×250mm)5μ column using a mixture of Methanol and water(60:40) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 224nm. The retention time of the Pseudoephedrine Hcl and Loratadine was 2.4, 4.7 ±0.02min respectively. The method produce linear responses in the concentration range of 24-120μg/ml of Pseudoephedrine Hcl and Loratadine 10-50 μg /ml of Pseudoephedrine Hcl and Loratadine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Pseudoephedrine Hcl and Loratadine, RP-HPLC, ICH validation. PDA detection; Tablet dosage form.