Development and validation of a rapid and sensitive LC-MS/MS method for the determination of aripiprazole in human plasma: Application to a bioequivalence study

• Autorzy: Patel D. S. , Sharma N. , Patel M. C. , Patel B. N. , Shrivastav P. S. , Sanyal M.
• Języki publikacji: EN

Abstrakty

EN

A rapid, selective, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of aripiprazole in human plasma. The analyte and propranolol as internal standard (IS) were extracted from 200 μL of human plasma via liquid-liquid extraction using methyl tert-butyl ether under alkaline conditions. The best chromatographic separation was achieved on an Aquasil C18 (100 × 2.1 mm, 5 μm) column using methanol-deionized water containing 2 mM ammonium trifluoroacetate and 0.02% formic acid (65:35, v/v) as the mobile phase under isocratic conditions. Detection of analyte and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The method was fully validated for its selectivity, interference check, sensitivity, carryover check, linearity, precision and accuracy, reinjection reproducibility, recovery, matrix effect, ion suppression/enhancement, stability, ruggedness, and dilution integrity. The assay was linear over the concentration range of 0.10–100 ng mL ^-1 for aripiprazole. The intra-batch and inter-batch precision (%CV) was ≤4.8%, while the mean extraction recovery was >96% for aripiprazole across quality control levels. The method was successfully applied to a bioequivalence study of 10 mg aripiprazole orally disintegrating tablet formulation in 27 healthy Indian subjects under fasting and fed condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 260 incurred samples.

Słowa kluczowe

EN

aripiprazole; LC-MS/MS; liquid-liquid extraction; human plasma; bioequivalence; incurred sample reanalysis

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 2
• Strony: 203--227
• Opis fizyczny: Bibliogr. 32 poz., rys., tab.

Twórcy

autor

Patel D. S.

• Pramukh Swami Science and H.D. Patel Arts College Chemistry Department Sarva Vidyalaya Campus Kadi 382 715 Gujarat India
• BA Research India Ltd. Bio-Analytical Laboratory Bodakdev, Ahmedabad 380054 Gujarat India

autor

Sharma N.

• BA Research India Ltd. Bio-Analytical Laboratory Bodakdev, Ahmedabad 380054 Gujarat India

autor

Patel M. C.

• Pramukh Swami Science and H.D. Patel Arts College Chemistry Department Sarva Vidyalaya Campus Kadi 382 715 Gujarat India

autor

Patel B. N.

• BA Research India Ltd. Bio-Analytical Laboratory Bodakdev, Ahmedabad 380054 Gujarat India
• Gujarat University Department of Chemistry, School of Sciences Navrangpura, Ahmedabad 380009 Gujarat India

autor

Shrivastav P. S.

• Gujarat University Department of Chemistry, School of Sciences Navrangpura, Ahmedabad 380009 Gujarat India

autor

Sanyal M.

• St. Xavier’s College Department of Chemistry Navrangpura, Ahmedabad 380009 Gujarat India

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