Development and validation of stability indicating LC-MS/MS Technique for the quantification of tapentadol in biological matrices: Application to bioavailability study in healthy rabbits

ABSTRACT

An Liquid chromatography tandem mass spectrometry (LC-MS/MS) technique is one of the best analytical methods for thequantification of drugs in biological samples. A stability-indicating analytical technique was developed for the quantitationof tapentadolin biological matrices as tapentadol with short runtime. Developed technique also suitable for bioavailabilitystudies in healthy rabbits. Separation of tapentadol and tapentadol-d3 were achieved from plasma sample with solid-phaseextraction and elution was processed with Luna-C18 (5 μ, 100 mm × 4.6 mm) stationary column with movable phase ratiocomprising 2-mM ammonium acetate buffer (pH-3.6) and acetonitrile in the proportion of 1090 % V/V. Quantitationwas processed by processing the transitions of tapentadol and tapentadol-d3 at m/z 222.2 → 177.1 and 228.2 → 183.1,respectively, in positive ionization mode. Linearity was performed over the concentration range of 0.121 to 35.637 mg/ml(R2 > 0.99) without matrix effect (2.74%). The inter- and intra-day precision findings were within 8.62% and 11.38%,respectively. Stability data showed that the tapentadol was stable when it exposed to different stability conditions. Thistechnique was effectively applied to bioavailability studies of tapentadol in healthy rabbits