Simultaneous Estimation of Paracetamol and Tapentadol in Bulk and Pharmaceutical Formulation by Reverse Phase High Performance Liquid Chromatography (RP-HPLC)

Abstract

Paracetamol and Tapentadol are both analgesic drugs. As there is no UV or HPLC method for the simultaneous estimation of Paracetamol and Tapentadol, a need was felt to develop the method for the analysis of both drugs simultaneously. This work concerns with the development and validation of a simple, specific and cost effective RP-HPLC method for simultaneous estimation of Paracetamol and Tapentadol in bulk and the developed method was applied to the pharmaceutical dosage form ie., Tapcynta. Chromatography was carried on Thermohypersil BDS C18 column with mobile phase comprising of Dihydrogen potassium phosphate buffer and Acetonitrile in the ratio of 50:50 v/v. The flow rate was adjusted to 0.9 ml/min with PDA detection at 218.6 nm. The retention times of Paracetamol and Tapentadol were found to be 4.8 min, 8.0 min respectively and other replicate standard system suitability parameters are within the limit and uniform. The different analytical parameters such as accuracy, precision, linearity, robustness, limit of detection (LOD), limit of quantification (LOQ) were determined according to the International Conference on Harmonization (ICH) Q2B guidelines. The detector response was linear in the range of 88044x + 19214 mg/ml, 49855x + 36868 mg/ml for Paracetamol and Tapentadol respectively. The proposed method was successfully applied for the reliable quantification of active pharmaceuticals present in the commercial formulations.