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Vol. 32 No. 10 (2020): Vol 32 Issue 10

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Development and Validation of UPLC-MS/MS Method for the Determination of Aripiprazole in Rat Plasma Using Liquid-Liquid Extraction: Pharmacokinetic and Bioequivalence Application

https://doi.org/10.14233/ajchem.2020.22899
Ashish Raghuvanshi
Department of Pharmaceutics, School of Pharmaceutical Science, Shri Venkateshwara University, Gajraula-244236, India
Urooj A. Khan
Nanoformulation Research Laboratory, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi-110062, India
Uzma Parveen
Department of E.N.T, Hayat Unani Medical College and Research Centre, Lucknow-226101, India
Anshul Gupta
Nanoformulation Research Laboratory, Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi-110062, India
Gaurav K. Jain
Department of Pharmaceutics, Delhi Pharmaceutical Science and Research University, New Delhi-110017, India

Corresponding Author(s) : Gaurav K. Jain

drgkjain@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 10 (2020): Vol 32 Issue 10

Abstract

A selective, simple, sensitive and rapid ultra-performance liquid chromatographic tandem mass spectrometric (UPLC-MS/MS) method for the detection of aripiprazole in rat plasma has been developed and validated using aripiprazole-D8 as internal standard (IS). A simple single step sample preparation process was accomplished by liquid-liquid extraction (LLE). The post-treatment samples were chromatographed and analyzed on a UPLC bridged ethyl hybrid (BEH) C-18 column using mobile phase composition of acetonitrile: 0.1% formic acid in water::70:30 (v/v). Aripiprazole was analyzed by MS detector in positive electrospray ionization mode (ESI). Multiple reactions monitoring (MRM) was employed to observed the transition for aripiprazole (m/z 448.35→285.09) and aripiprazole-D8 (m/z 456.2→293.2). The developed method was validated and found linear in the working range of 2-1025 ng/mL with correlation coefficient, r2 = 0.99951 and quantification limit of 2.02 ng/mL. All validation parameters were in accordance with the ICH guidelines and met the acceptance criteria. The method was found to be accurate (recovery, 97.07 to 103.64%, precise (% CV, 2.68 to 7.70%), rapid (run time 4 min) and specific. The validated method was successfully used for the determination of plasma concentration of aripiprazole after single oral administration in rats and hence could be useful for in vivo pharmacokinetic study and bioequivalence testing of aripiprazole formulations.

Keywords

Aripiprazole Mass spectrometric Rat plasma Ultra performance liquid chromatographic
Raghuvanshi, A., A. Khan, U., Parveen, U., Gupta, A., & K. Jain, G. (2020). Development and Validation of UPLC-MS/MS Method for the Determination of Aripiprazole in Rat Plasma Using Liquid-Liquid Extraction: Pharmacokinetic and Bioequivalence Application. Asian Journal of Chemistry, 32(10), 2671–2676. https://doi.org/10.14233/ajchem.2020.22899
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