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International Journal of Pharmaceutical Chemistry and Analysis


Development of Quality Control Method for Dissolution Analysis of Tapentadol and paracetamolin tablet


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Author Details: Krishna R Gupta, Kiran N. Kale

Volume : 3

Issue : 2

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 56

Article End Page : 65


Abstract

The aim of present study was to develop and validate a dissolution test method for film coated formulation containing tapentadol and paracetamol, using RP-HPLC method. The optimized dissolution conditions includes USP apparatus II at a paddle rotation rate of 50 rpm and 900 ml of 6.8 pH Phosphate buffer at 37°C± 0.5°C. Under these conditions, the in vitro release profiles of tapentadol and paracetamol showed good results. The drug release was estimated by RP-HPLC using column Hyperchrom ODS 5µ C18 (250 x 4.6mm, 100°A), detection wavelength 217 nm having the flow rate 1.0mL/min using ACN: Potassium dihydrogen phosphate buffer in the proportion of 35:65and adjusted pH to 2.8 with orthophosphoric acid. The method validation was carried out as per for USP guidelines and it was found that the results obtained by proposed method for dissolution test for tablet formulation containing Tapentadoland paracetamol are reliable, precise and accurate. Hence it was routinely adopted for dissolution analysis of the said drugs in the formulation.

Keywords: Dissolution testing, Tapentadol, Paracetamol, Validation, High performance liquid chromatography