DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC (HPTLC) METHOD FOR ESTIMATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS TABLET DOSAGE FORMAbstract
A simple, accurate, rapid and sensitive high performance thin layer chromatographic method has been developed for the estimation of Tapentadol Hydrochloride in bulk and its tablet dosage form. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of methanol: toluene (4:1v/v). Densitometric evaluation of the separated zones was performed by UV detector at 272 nm. The drug was satisfactorily resolved with Rf value 0.5 ± 0.02.The method was linear over concentration range of 1500-2000 (1.5-2.0 µL) ng/spot. The analytical percent recovery was found to be 99.92%.The intra and interday precision with percent relative standard deviation (%RSD) values in the range of 0.0895 to 0.0892. The validation of the method was carried as per ICH guidelines. The proposed HPTLC method was successfully employed for routine analysis of bulk drug and its commercial tablet dosage form.
Pragati Amin*, Manisha Tayde and Prakruti Amin
Department of Pharmaceutical Chemistry, M.G.V'S Pharmacy College, Panchavati, Nasik, Maharashtra, India
13 January, 2014
31 March, 2014
03 May, 2014
01 July, 2014