RP-HPLC method development and validation of tadalafil in tablet dosage form

Alivelu Samala, Santhosh Pawar

Abstract

Tadalafil is a PDE5 inhibitor, indicated for the treatment of erectile disfunction. The objective of this study is to develop a simple and accurate RP-HPLC method for the estimation of Tadalafil in tablet dosage form. A sharp peak was obtained at 3.068min, on a Agilent Eclipse XBD C18 column (150 X 4.6mm i.d., 5μm particle size) with mobile phase, acetonitrile and buffer solution (50:50v/v), delivered in isocratic mode at a flow rate of 1.2ml/min. at 282nm, methanol was used as diluent. The linear dynamic response was found to be in the concentration range of 10- 150μg/ml and shows a correlation coefficient (R2) of 0.999. Accuracy was determined by recovery studies from tablet dosage form and ranges from 100.3-100.8%. The intraday and interday precision was found to be 0.54% and 0.52% respectively.

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