An LC-MS/MS technique is one of the best analytical tools for the quantification of drugs in biological samples. A stability-indicating analytical technique was developed for the quantitation of tapentadol in biological matrices as tapentadol with short runtime. Developed technique also suitable for bioavailability studies in healthy rabbits. Separation of Tapentadol and tapentadol-d3 internal standard were achieved from human plasma with solid-phase extraction and elution was processed with Luna-C18 (5 μ, 100 × 4.6 mm) column with mobile phase ratio comprising of ammonium acetate (2 mM) buffer pH-3.6 and acetonitrile in the proportion of 10:90 % V/V. Quantitation was processed by monitoring 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 tapentadol was stable when it exposed to different stability conditions. This technique was successfully applied to bioavailability study of tapentadol in healthy rabbits.
Key words: Tapentadol, Liquid chromatography-mass spectrometry, Validation, Matrix effect, Healthy rabbits and Bioavailability study.
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