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Published: 2024-08-24

Keywords:Paracetamol, Tapentadol, Simultaneous, Estimation, HPLC.

ABSTRACT

Paracetamol and tapentadol are both pain relievers. Since there is no UV or HPLC method for the simultaneous evaluation of paracetamol and tapentadol, it was considered necessary to develop a method for the simultaneous analysis of both drugs. This work deals with the development and validation of a simple, specific and cost-effective RP-HPLC method for the simultaneous bulk estimation of paracetamol and tapentadol and the developed method was applied to pharmaceutical dosage form viz. Tapcynta. Chromatography was performed on a Thermohypersil BDS C18 column with a mobile phase of 50:50 v/v potassium dihydrogen phosphate buffer and acetonitrile. 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 minutes, 8.0 minutes and other appropriate parameters of the reproduced standard system are within limits and consistent. Various 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. For paracetamol and tapentadol, the detector response was linear between 88044x + 19214 mg/ml, 49855x + 36868 mg/ml. The proposed method was successfully applied for the reliable quantification of active drugs in commercial formulations.