Open AccessDevelopment and Validation of UPLC-MS/MS Method for the Determination of Aripiprazole in Rat Plasma Using Liquid-Liquid Extraction: Pharmacokinetic and Bioequivalence Application
Author(s) -
Ashish Raghuvanshi,
Urooj Ahmed Khan,
Uzma Parveen,
Anshul Gupta,
Gaurav Jain
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22899
Subject(s) - chemistry , aripiprazole , chromatography , bioequivalence , formic acid , pharmacokinetics , selected reaction monitoring , electrospray ionization , detection limit , high performance liquid chromatography , extraction (chemistry) , mass spectrometry , tandem mass spectrometry , pharmacology , medicine , schizophrenia (object oriented programming) , computer science , programming language
A selective, simple, sensitive and rapid ultra-performance liquid chromatographic tandem massspectrometric (UPLC-MS/MS) method for the detection of aripiprazole in rat plasma has been developedand validated using aripiprazole-D8 as internal standard (IS). A simple single step sample preparationprocess was accomplished by liquid-liquid extraction (LLE). The post-treatment samples werechromato-graphed and analyzed on a UPLC bridged ethyl hybrid (BEH) C-18 column using mobilephase composition of acetonitrile: 0.1% formic acid in water::70:30 (v/v). Aripiprazole was analyzedby 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 of2-1025 ng/mL with correlation coefficient, r2 = 0.99951 and quantification limit of 2.02 ng/mL. Allvalidation 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 determinationof plasma concentration of aripiprazole after single oral administration in rats and hence could beuseful for in vivo pharmacokinetic study and bioequivalence testing of aripiprazole formulations.