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Development and validation of a rapid RP-HPLC method for the determination of tadalafil in bulk and in formulation

K.Anandakumar, K.Varadharajan, D.Jothieswari, R.Subathrai, G.Sivanseyal, J.Suresh

Asimple, selective, linear, precise and accurate RP-HPLC method was developed and validated for assay of Tadalafil in bulk and in tablet dosage forms. Isocratic elution at a flow rate of 0.9 ml/ min was employed on a Phenomenax Luna C18 column (1504.6 mm; 5) at ambient temperature. The mobile phase consisted of acetonitrile and water (50:50% v/v). The detection wavelength was 295nm and 25l of sample was injected. Lamotrigine was used as an internal standard (IS). The retention times for TDF and IS were 4.12 and 2.29 min, respectively. Themethod obeys Beer’s law in the concentration range of 1-5g/ml. The method was successfully applied to commercial pharmaceuticals and validated as per standard analytical procedures. The proposed method could be applicable for routine analysis of TDF in bulk and in formulations.