Development and validation of RP-HPLC method for the estimation of tadalafil in bulk and pharmaceutical dosage forms

Abstract

A rapid, sensitive, efficient, and reproducible method for the determination of Tadalafil has been developed using reverse phase high performance liquid chromatographic method. This method involves separation of Tadalafil on a reversed phase Agilent Zorbax poroshell 120EC-C18 RP column, 100×4.6 mm, 2.7 µ. The elution was done using a mobile phase consisting of acetonitrile and water (40:60 % v/v) on AGILENT 1120 COMPACT LC HPLC. An external standard calibration method was employed for quantification. A survey of literature revealed spectrophotometric, capillary electrophoresis and a few chromatographic methods for the determination of Tadalafil in bulk drug. Compared to the already reported RP HPLC methods, the current method is rapid, simple and economical for the determination of Purity, accuracy, linearity and Assay of Tadalafil in bulk drug and in pharmaceutical dosage forms.