Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to Bioequivalence Study

Abstract

Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. The objective of the current study was to develop a sensitive, fast and high-throughput HPLC-ESI-MS/MS method to measure etoricoxib levels in human plasma using a one-step methanol protein precipitation technique. A tandem mass spectrometer equipped with an electrospray ionization (ESI) source operated in a positive mode and multiple reaction monitoring (MRM) were used for data collection. The quantitative MRM transition ions were m/z 359.15 > 279.10 and m/z 363.10 > 282.10 for etoricoxib and IS. The linear range was from 10.00 to 4000.39 ng/mL and the validation parameters were within the acceptance limits of the European Medicine Agency (EMA) and Food and Drug Analysis (FDA) guidelines. The present method was sensitive (10.00 ng/mL with S/N > 40), simple, selective (K prime > 2), and fast (short run time of 2 min), with negligible matrix effect and consistent recovery, suitable for high throughput analysis. The method was used to quantitate etoricoxib plasma concentrations in a bioequivalence study of two 120 mg etoricoxib formulations. Incurred sample reanalysis results further supported that the method was robust and reproducible.

Quantification of Etoricoxib in Low Plasma Volume by UPLC-PDA and Application to Preclinical Pharmacokinetic Study

“…Etoricoxib was also quantified in rat plasma by means of LC-MS [ 11 , 12 ] and HPLC-UV [ 13 ]. The LC-MS/MS tool is both fast and sensitive [ 10 , 14 ]; however, this advanced equipment is only affordable for some laboratories. Meanwhile, due to relatively low costs, UPLC with UV (UPLC-UV) or, preferably, photodiode array (UPLC-PDA) detection, is affordable, and can allow rapid analysis with good sensitivity [ 15 , 16 ].…”

Novel RP‐HPLC method for estimation of a newly developed combination of tizanidine and etoricoxib in rat plasma: Eight criteria for greens evaluation

“…Several methods have been developed to determine TIZ in its pure and pharmaceutical forms while ETC has been quantified using various techniques, including HPLC, [14][15][16][17][18][19][20][21][22] UPLC, [23][24][25] and LC/MS. [26][27][28][29][30] No developed HPLC method has been published for the concurrent quantification of both medicines in a pharmaceutical formulation or rat plasma. We propose using DIC as an internal standard and implementing a green chromatography approach to ensure analyst and environmental safety.…”