Tapentadol hydrochloride (TPHCL), is a centrally acting analgesic drug with a dual mechanism of action involving mu-opioid receptor agonism and nor epinephrine reuptake inhibition. A rapid, sensitive, simple and cost-effective high performance liquid chromatographic method for the determination of TPHCL by UV detection in rat plasma is to be developed and validated. Extraction process involved is protein precipitation using diethyl ether: dichloromethane (60:40 v/v). TP HCL was eluted under isocratic mode using an Altima Grace Smart C18 column. The mobile phase consists of 60:40 v/v methanol: 20mM sodium perchlorate buffer (pH 6.8) at flow rate of 1.0 ml/min with wavelength of detection at 236 nm. The injection volume was 20 μl. The runtime of the method was 10 min. The method exhibited good linearity in the range 50-250 ng/ml. The correlation coefficient (r2) value was found to be 0.998. Precision study showed % CV value less than 2% in all selected concentrations. The lower limit of quantitation (LLOQ) was found to be 50ng/mL. While, accuracy of LLOQ was found to be 94.60±7.57 % and %RSD was 8.00% while the intra- and inter-day accuracies were around accuracies were 98.28-102.99% respectively. A rapid, sensitive, simple and cost effective method for the estimation of Tapentadol in human plasma was developed and validated according ICH guidelines.
Impact Factor
2022: 6.012
This work is licensed under a