Development and Validation of A Stability Indicating RP-HPLC Method for Determination of Tapentadol in Tapentadol Hydrochloride Tablets
Journal Title: International Journal of Research in Pharmacy and Science - Year 2013, Vol 3, Issue 2
Abstract
A simple, precise, rapid and accurate stability indicating reversed-phase high performance liquid chromatography (RP-HPLC) method is developed for the estimation of tapentadol in tapentadol hydrochloride tablets. The separation was achieved by using a Waters 2695 HPLC System consisting of analytical column Eclipse XDB-C18 (5µm; 150x4.6mm) and wavelength detector- Waters 2489 UV is used for analysis. The mobile phase consisting of A- phosphate buffer (pH 6.5±0.05): methanol in the ratio of 65:35 (v/v) is used. The flow rate is 1.0 mlm-1 and the effluents are monitored at 210 nm. The retention time is about 12.0 m. The detector response is linear in the concentration range of 50.0-150.0 µgml-1. The respective linear regression equation being y = 956825 + 569233. The percentage assay of tapentadol is 99.65%. The method is validated as per ICH guideline by determining its specificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability. The results of the study show that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of Tapentadol in tablet dosage form.
Authors and Affiliations
Pradeep Kumar Singh, Subas Dinda
Keywords
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