ABSTRACT:
A simple selective precise and stability-indicating high performance thin layer chromatographic method of analysis of Pentoxifylline, both as a bulk drug and in formulations was developed and validated. The method employed TLC (Thin Layer Chromatography) aluminum plates pre-coated with silica gel 60 F254 as the stationary phase. The solvent system consisted of chloroform : acetone (5:5, v/v). This system was found to give compact spots for Pentoxifylline (Rf , retardation factor, value–0.48). Pentoxifylline was subjected to hydrolytic, oxidative, dry heat and photo-degradation. The responses for products of degradation were well separated from the pure drug. Densitometric analysis of Pentoxifylline hydrochloride was carried out in the absorbance mode at 275 nm. The linear regression analysis data for the calibration spots showed good relationship with (regression) r2 = 0.9947 in the range of 200–2000 ng (nanogram). The limits of detection and quantatition were 43.90 ng/spot and 131.73 ng/spot, respectively. The drug does not undergo degradation with acidic hydrolysis and oxidative conditions, but gets affected in and alkaline hydrolytic and neutral hydrolytic conditions. As the method could effectively resolve the drug from its degradation products, it can be employed as a stability-indicating one.