validation

  Quantitative estimation of Trapidil and its pharmaceutical dosage form by HPLC, HPTLC and UV spectroscopy methods was developed. In the RP-HPLC method, the drug was resolved using a mobile phase phosphate buffer: acetonitrile (30:70%v/v) with pH adjusted to 3.5 using phosphoric acid on C18 column in isocratic mode. The retention time of trapidil was found to be 3.195 min.  In HPTLC method, the chromatograms were developed by using a mobile phase Methylene chloride: Methanol:  ammonia (8.5:1:0.5 v/v) on precoated plate of silica gel 60F254 and quantified by densiometric absorbance mode at 312nm. The Rf value of Trapidil was 0.28. In the UV method, trapidil was quantified at 221nm in acetronitrile. Recovery studies of 98.8-101.14%, percentage relative standard deviation (%RSD less than 2%) and correlation coefficient (linearity range) that developed methods were accurate and precise. These methods can be employed for the routine analysis of tablets containing trapidil.   Key words: Trapidil, RP-PHLC, HPTLC, UV spectrophotometry, validation

  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.