Objective: A simple, sensitive and rapid LC-MS/MS technique was developed for the quantitation of trandolapril (TDL) and verapamil (VPL) in a biological matrix and validated. Methods: Sample preparation processed by SPE (Solid Phase extraction) on phenomenex cartridge using Ledipasvir as an internal standard. Two drugs were eluted on waters symmetry-RP18 (5µ, 150 mm×4.0 mm) column with the mobile composition of 10 mmol ammonium formate and ACN(acetonitrile) in the ratio of 70:30 %V/V. Detection and quantitation were processed by electrospray ionization in positive ionization mode. Results: The quantification approach was validated in 5-1500 ng/ml linear concentration range for TDL and 1-2000 ng/ml for VPL. The intraday and inter-day precision and accuracy were found to be 0.58% to 5.69% and 93% to 104% for two drugs. The average recoveries for TDL and VPL were found to be 92.9% and 93.5% respectively. Conclusion: The developed work was validated and can be applicable to the routine analysis of TDL and VPL simultaneously in a biological matrix.
Background: A simple quantification technique by liquid chromatography–electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) is required for regorafenib in biological matrices with bioavailability studies in healthy rabbits, when compared with reported techniques. Objective: The main aim of the research work is to develop a validated LC-ESI-MS/MS technique for the quantification of regorafenib and application to bioavailability studies in healthy rabbits. Methods: Chromatographic separation was achieved with hypersil-C18 analytical column (50mm×4.6 mm, 4µm) and a mobile phase composition of acetonitrile and 5mM ammonium acetate in the proportion of 70:30. The mobile phase was infused into the column with high pressure to get 0.7 ml/min flow rate. The total retention time of the analyte is promising when compared with the existed methods for regorafenib. Quantitation was processed by monitoring transitions of m/z -483.0/262.0 and 450.0/260.0 for regorafenib and internal standard respectively in multiple reaction monitoring. Results: The linearity equation and correlation coefficient (R2) findings were y =0.9948x+2.6624 and 0.998 respectively. The intra and inter-day precision of the developed technique was found between 1.00 – 8.50% for the QC-samples (2, 4, 240 and 480ng/ml). From bioavailability study, the drug was shown Tmax of 3.688 ± 0.754; average AUC0͢α and AUC0͢t was 6476.81 ± 259.59 and 6213.845 ± 257.892 and Cmax was found to be 676.91 ± 22.045 in healthy rabbits. Conclusion: The developed technique was validated and successfully applied in the pharmacokinetic study of drug (40 mg tablet) administered through oral route in healthy rabbits.
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