Quality by Design enabled enhanced bioanalytical extraction and UFLC determination of vilazodone from rat serum

ABSTRACT

An ultrafast liquid chromatographic bioanalytical method was developed and validated for the determination of vilazodone in Wistar rat serum. Principles of quality by design were implemented for enhancing the bioanalytical liquid–liquid extraction of vilazodone from rat serum. A Box–Behnken design was utilized in the studies by selecting extraction time, centrifugation speed, and vortex time as the critical method variables for evaluating their effect on the analytical attribute, i.e., %recovery of vilazodone. Chromatographic separation was achieved within a run time of 10 min using a C-18 column and mobile phase comprising of methanol:phosphate buffer of pH 7 (85:15 v/v) flowing at 1.5 mL/min. Photodiode array detection was performed at 242 nm. Results of validation studies were satisfactory. The method was linear over a concentration of 100–2,000 ng/mL with acceptable accuracy and precision. Limits of detection and quantitation for the developed method were 50 and 100 ng/mL, respectively. This QbD-based approach was found suitable for routine bioanalysis of vilazodone in the biological matrix.

GRAPHICAL ABSTRACT

KEYWORDS:

• Bioanalysis
• Box–Behnken design
• liquid–liquid extraction
• quality by design
• ultrafast liquid chromatography
• vilazodone

Acknowledgments

The authors are thankful to Glenmark Pharmaceuticals Ltd. for providing the reference standard of VLN and Principal, Roland Institute of Pharmaceutical Sciences, Khodasingi, Berhampur, India for providing the necessary research facilities.