Sensitive LC-MS/MS Method for the Simultaneous Determination of Bisoprolol and Triamterene in human plasma
Objective: A highly sensitive, specific, and rapid liquid chromatography-electrospray ionization-mass spectrometry (MS)/MS method has beenÂ developed and validated for the simultaneous quantification of bisoprolol and triamterene in human plasma using metoprolol as an internalÂ standard (IS) as per regulatory guidelines.
Methods: Both the analytes and IS were extracted from plasma using a protein precipitation extraction method. Chromatography was achieved onÂ Welchrom XB C18, 50 mmÃ—4.6 mm, 5 Âµm column using an isocratic mobile phase (2 mM ammonium formate acetonitrile, 70:30 v/v) at a flow rate ofÂ 0.60 ml/minute.
Results: The total chromatographic run time was 3.5 minute and the elution of bisoprolol, triamterene, and IS occurred at ~2.57, 1.30 and 1.57 minute,Â respectively. A linear response function was established at 2.04-210 ng/ml for both the analytes in human plasma. The intra- and inter-day accuracyÂ and precisions were in the range of 1.12-7.87 and 1.26-6.36%; 1.46-6.13 and 1.65-7.34% for bisoprolol and triamterene, respectively.
Conclusion: A new robust method was developed for simultaneous determination of Bisoprolol and Triamterene in human plasma. The method wasÂ strictly validated according to the ICH  guidelines. The information thus obtained from the study can be used for the full pharmacokinetic profilingÂ in individuals.
Keywords: Bisoprolol, Triamterene, Liquid chromatography-mass spectrometry/mass spectrometry, Method validation, Human plasma,
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