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Determination and quantitation of benzofuran, Indole and piperazine containing selective serotonin reuptake inhibitor vilazodone hydrochloride in human plasma by LC-ESI-MS/MS with an application to pharmacokinetic study under the frame work of bioequivalence study


Journal of Analytical & Pharmaceutical Research
Balaram Ghosh,2 Pallab Mandal,1 Soumya Chakraborty,1 Rakesh Bera,1 Chiranjit Saha,Sourav Poddar,3 Sujata Barma,4 Jasmina Khanam,4 Sanmoy Karmakar,4 Tapan  Kumar Pal1

Abstract

Aim and objectives: Among the various SSRI and 5-HT-1A, partial agonist vilazodone is one of them. It has antidepressant and anti-anxiety activities. This method’s main aim and the objective was to develop and validate a bio-analytical method of Vilazodone in human plasma by LC-MS/MS (API-4000) and its application to estimate pharmacokinetics.

Method: For reporting this investigation, Analyst software, 1.6.3 used. The mobile phase was acetonitrile with 0.1% formic acid as an organic solvent and Milli Q water with 10Mm ammonium acetate and 0.1% formic acid using the gradation method 7.0min run time. The calibration standard concentrations were 1.0 to 64 ng/ml. Plasma precipitation was by protein precipitation technique.

Result: The accuracy of calibration concentrations of Vilazodone was 93.5-104.39% and stability  study  showed  96.41-106.71%,  94.77-96.36%,  92.22-101.38%,  94.15-98.47%, 93.95-95.75% remaining for freeze-thaw, short term, long term, benchtop and autosampler stability respectively. Recovery was to be 98.10-98.99%; the matrix factor was 0.94-0.96. The maximum plasma concentration of reference preparation was 13.445±2.842ng/ml (Cmax) at a time 6.792±0.846hr. (Tmax). The maximum plasma concentration of test preparation was 13.218±3.231ng/ml (Cmax) at a time 6.958±0.793hr (Tmax) The relative bioavailability of the test preparation was to be 94.66 % of that of the reference preparation.

Conclusion: The  present  investigation  was  highly  selective,  sensitive,  reproducible,  low  matrix  effect,  high  recovery  and  low  time-consuming  method.  It  was  validated  as  per USFDA and EMA guideline and successfully used in comparative pharmacokinetics.

Keywords

vilazodone, LC-MS/MS-ESI, Human volunteers, BA/BE study

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