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Development and Validation of an HPLC Method for Analysis of Tadalafil in Human Plasma


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1 Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
     

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A simple high-performance liquid chromatographic method for the determination of tadalafil in human plasma has been developed. Separation was achieved by Reverse phase chromatography on a Grace Genesis C18 (150 x 4.6 mm, 5μ) column with mobile phase A containing Triethylamine buffer (pH adjusted to 2.5±0.05 with Orthophosphoric acid) and mobile phase B containing Acetonitrile 95%(95:5 (Acetonitrile:water)) as eluent at a flow rate 1.2ml/min. UV detection was performed at 225nm. Lower limit of quantitation was 4.997ng/ml. Maximum between-run precision was 2.085%. Mean extraction recovery was found to be 97.38 to 97.45%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 48h and at -20° for 2months. Before injecting onto HPLC system, the processed samples were stable for at least 6h. The method can be used to perform bioequivalence study in human.
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  • Development and Validation of an HPLC Method for Analysis of Tadalafil in Human Plasma

Abstract Views: 188  |  PDF Views: 0

Authors

G. V. H. Raju
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
S. Ganapathy
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
D. G. Sankar
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India
P. Y. Naidu
Department of Pharmaceutical Sciences, Andhra University, Visakhapatnam-530003, India

Abstract


A simple high-performance liquid chromatographic method for the determination of tadalafil in human plasma has been developed. Separation was achieved by Reverse phase chromatography on a Grace Genesis C18 (150 x 4.6 mm, 5μ) column with mobile phase A containing Triethylamine buffer (pH adjusted to 2.5±0.05 with Orthophosphoric acid) and mobile phase B containing Acetonitrile 95%(95:5 (Acetonitrile:water)) as eluent at a flow rate 1.2ml/min. UV detection was performed at 225nm. Lower limit of quantitation was 4.997ng/ml. Maximum between-run precision was 2.085%. Mean extraction recovery was found to be 97.38 to 97.45%. Stability study showed that after three freeze-thaw cycles the loss of three quality control samples were less than 10%. Samples were stable at room temperature for 48h and at -20° for 2months. Before injecting onto HPLC system, the processed samples were stable for at least 6h. The method can be used to perform bioequivalence study in human.