Thu, 14 Dec 2017

HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF TADALAFIL IN TABLET DOSAGE FORM

Satish A. Patel *, Natvarlal J. Patel

 

1.Department of Pharmaceutical Quality, Assurance Shree S. K. Patel College of Pharmaceutical Education & Research, Ganpat University, Kherva – 382711, Mehsana, Gujarat, India


ABSTRACT

 

A simple and sensitive high performance thin layer chromatography (HPTLC) method has been developed for the quantitative estimation of Tadalafil in its single component tablet formulation (20 mg). Tadalafil was chromatographed on silica gel 60 F254 TLC plate using chloroform: methanol (9:1, v/v) as mobile phase. Tadalafil showed Rf value 0.78 + 0.008 and scanned at 285 nm using a camag TLC scanner 3. The method was validated in terms of linearity (100 – 800 ng/spot), precision (intra-day variation, 0.38 to 0.81% and inter-day variation, 0.45 to 1.90%), accuracy (100.3 ± 0.76) and specificity. The limit of detection and limit of quantification for Tadalafil were found to be 28.11 ng/spot and 93.45 ng/spot, respectively. The developed method was successfully used for the assay of Tadalafil tablet formulation. The method was found to be simple, sensitive, specific, accurate and precise and can be used for the routine quality control testing of Tadalafil in tablet dosage form.

Keywords: Tadalafil, HPTLC, validation, tablet


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