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

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.

Investigating the Role of the Reduced Solubility of the Pirfenidone–Fumaric Acid Cocrystal in Sustaining the Release Rate from Its Tablet Dosage Form by Conducting Comparative Bioavailability Study in Healthy Human Volunteers

“…Frozen plasma samples were first thawed at room temperature and plasma extraction was performed by the protein precipitation technique . One hundred microliters of plasma was taken and precipitated with 400 μL of acetonitrile containing 10 μg/mL propranolol (IS) and vortexed for 10 min followed by centrifugation for 10 min at 10,000 rpm at 4 °C.…”

“…Frozen plasma samples were first thawed at room temperature and plasma extraction was performed by the protein precipitation technique. 64 One hundred microliters of plasma was taken and precipitated with 400 μL of acetonitrile containing 10 μg/mL propranolol (IS) and vortexed for 10 min followed by centrifugation for 10 min at 10,000 rpm at 4 °C. Three hundred microliters of supernatant was taken, filtered using a syringe filter (0.45 μm), diluted 10 times, and then transferred into autosampler vials for injection.…”

Zinc Oxide Nanoparticles as Efficient Heterogeneous Catalyst for Synthesis of Bio‐active Heterocyclic Compounds

“…Since they are key structural subunits in natural compounds that have incredible medicinal properties. A lot of study has been done on how to make benzofuran derivatives to produce new drug molecules [140–143] …”

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

“…Thorough literatures survey was carried out to judiciously assess the qualitative and quantitative analytical methods reported for the determination of vilazodone. There are several analytical methods available to estimate vilazodone in bulk pharmaceuticals and biological matrix including HPLC [8][9][10][11][12][13][14][15][16][17], Spectroscopic [18], HPTLC [19], Spectrophotometric [20,21], Spectro uorometric [22] and LC-MS/MS [23][24][25][26][27][28][29][30][31][32]. However, all reported methods other than LC-MS/MS are associated with several limitations such as sensitivity, higher analysis time and only used for the analytical quality control research purposes.…”

“…However, all reported methods other than LC-MS/MS are associated with several limitations such as sensitivity, higher analysis time and only used for the analytical quality control research purposes. Whereas published LC-MS/MS methods are developed in rat plasma [25,26,28,30], dog plasma [29], human plasma [27,31]. All methods described the inadequate validation range which is most crucial for the reliable estimation of plasma concentration and evaluation of pharmacokinetic parameters, usage of high plasma volume and solvent consumptions is quite more.…”