Ultrafast Bioanalytical Assay for Vilazodone Quantification in Human Plasma Using Vilazodone D8 Internal Standard by Uplc- Ms/ms

Abstract

A selective and highly sensitive quantitative method has been established for assessment of pharmacokinetic parameters in human plasma using vilazodone D8 as a labelled internal standard. Liquid- Liquid extraction technique (LLE) was applied for plasma sample extraction. Mass detection was performed in positive electro spray ionization method. Quantitation was achieved by monitoring sum multiple transitions of m/z 442.022 → 155.000 + 197.000 for vilazodone and 450.093 → 157.000 + 205.000 for vilazodone D8. Chromatographic separation was performed on reverse phase Betabasic C8, 100*4.6mm, 5µ column with 0.700mL/min flow rate. Mobile phase consists of acetonitrile and 0.1% formic acid in water (60:40%v/v) was pumped through isocratic mode. The linearity of the method was validated from range 0.300ng/mL to 300.000ng/mL. Precision and accuracy batches were found to be consistent, reproducible and acceptable within the defined limits across the validation. No matrix effect was observed within the validated range and extraction efficiency or recovery was found to be consistent and reproducible at all concentration levels (low, middle and high). The stock solutions, working solutions, plasma samples and processed samples were found to be stable under all defined conditions. In this validated method, selective linearity range were used to cover quantitative analysis for various strength formulations. This work was typically aimed to develop a method with shorter analysis time and simple extraction procedure for reliable measurement of clinical samples. The validated method can be useful in determining plasma concentration of vilazodone for therapeutic drug monitoring and in high throughput clinical bio-studies.