Abstrakt

Development and Validation of Reversed Phase High Performance Liquid Chromatography Method for Determination of Tapentadol in Pharmaceutical Formulation.

B Mohammed Ishaq, K Vanitha Prakash, and G Krishna Mohan

Tapentadol (TPL) is a novel opioid pain reliever drug. The present work explains the development and validation of a simple and reliable liquid chromatographic method for the quantitative determination of Tapentadol (TPL) in bulk and in tablet formulation. Chromatography was carried out by reversed phase technique on a C-8 column with a mobile phase composed of 0.1 M Dipotassium Phosphate buffer (pH 6.8) and acetonitrile in the ratio of 50:50 v/v pumped at a flow-rate of 1.2 ml/min. The detection was carried out at 241 nm at the column temperature of 45°C. The method was evaluated according to ICH guidelines for the various validation parameters, such as linearity, accuracy, precision, LOD, LOQ, specificity, and Forced degradation studies. The analyte peak appears at 2.47 mins. The calibration curve for tapentadol was linear from 200 to 600μg/ml. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of tapentadol in bulk and its tablet dosage forms. LOD and LOQ were found to be 0.001 μg/ml and 0.003 μg /ml respectively. Accuracy (mean recovery: 100.00%) and reproducibility were found to satisfactory. In conclusion, this was a simple and effective method using HPLC to detect TPL in tablet formulation, which may be useful for routine quality control analysis.