Analytical method development and validationof tadalafil by using RP-hplc method
Abstract
A new, simple, rapid, accurate and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Tadalafil, in Active pharmaceutical Ingredient form as well as in combined tablet dosage form. Chromatography was carried out on Symmetry ODS C18 (4.6mm × 250mm, 5μm) column using a mixture of Methanol: Acetonitrile (35:65v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 220 nm. The retention time of the Tadalafil was 2.885± 0.02min respectively. The method produces linear responses in the concentration range of 30-70mg/ml of Tadalafil. The mean % assay of marketed formulation was found to be 100.04%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%. The developed method is simple, precise and rapid, making it suitable for estimation of Tadalafil in API and combined tablet dosage form. The method is useful in the quality control of bulk and pharmaceutical formulations.
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