Objective: A highly sensitive, specific, and rapid liquid chromatography-electrospray ionization-mass spectrometry (MS)/MS method has been developed and validated for the simultaneous quantification of bisoprolol and triamterene in human plasma using metoprolol as an internal 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 on Welchrom XB C18, 50 mm×4.6 mm, 5 µm column using an isocratic mobile phase (2 mM ammonium formate acetonitrile, 70:30 v/v) at a flow rate of 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, 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 accuracy 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 was strictly validated according to the ICH [1] guidelines. The information thus obtained from the study can be used for the full pharmacokinetic profiling in individuals.Keywords: Bisoprolol, Triamterene, Liquid chromatography-mass spectrometry/mass spectrometry, Method validation, Human plasma,Pharmacokinetics.
A reliable, simple, robust and sensitive LC-MS/MS (Liquid Chromatography tandem Mass Spectrometric) method has been developed and validated that employs protein precipitation extraction method for the simultaneous determination of Pioglitazone and Voglibose in human plasma by using miglitol as internal standard. Chromatography conditions included an isocratic mobile phase composing of 5 mM ammonium formate buffer: acetonitrile in the ratio 50:50 V/V. the column used was Welchrom XB C18, with specifications of 50×4.6 mm, 5 μm, at a flow rate of 0.80 mL/min. the retention time of Pioglitazone, voglibose and miglitol occurred at ~2.83, 0.8 and 0.70 min, respectively and the total chromatographic run time was 4.0 min. Pioglitazone and voglibose achieved a linear response function in human plasma at 1.07-958 ng/mL & 2.02-203 ng/mL respectively. Pioglitazone and voglibose attained an intra and inter-day accuracy and precision at 0.93 – 7.54% and 0.96 - 5.39%; 0.74 - 7.1 and 0.9 - 3.75% range respectively. the International Conference on Harmonisation of technical Requirements for Registration of Pharmaceuticals for Human Use guidelines were used as the bench mark for validating the method.
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