title: Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study.
abstract: A selective, sensitive, high pressure liquid chromatography-positive electrospray ionization tandem mass spectrometry method was developed and validated for the quantification of aripiprazole in human K(2)EDTA plasma using zolpidem tartrate as an internal standard. The analyte and internal standard were extracted from human plasma by solid-phase extraction using methanol. The eluted samples were chromatographed on a Grace Smart RP 18 4.6 × 100 mm, 3 µ column by using a 95:5 v/v mixture of methanol and ammonium acetate buffer (30 mM, pH 5.0 ± 0.05) as a gradient mobile phase at a flow rate of 0.6 mL/min, and analyzed by mass spectrometry in the multiple reaction monitoring mode using the [M + H](+) ions m/z 448.03 → 285.14 for aripiprazole and m/z 308.13 → 235.25 for the internal standard (zolpidem tartrate), respectively. Calibration plots were linear over the concentration range of 0.20 to 60.01 ng/mL. Intra-day and inter-day precision (percent coefficient of variation) and accuracy (percent nominal) for quality control samples (0.60, 30.60 and 45.59 ng/mL) ranged between 2.28 and 8.93% and between 92.50 and 107.07%, respectively. Extraction recovery of aripiprazole from plasma was in the range 75.56-79.57%; mean recovery was 77.35%. The main pharmacokinetic parameters were T(max) = (4.00 ± 2.336) C(max) = (55.16 ± 13.490) and AUC = (1846.28 ± 484.686).
authors: Department of Clinical Pharmacology, APL-Research Centre, Bachupally, Quthubullapur mandal, Hyderabad, AP, India. r_sreedasyam@yahoo.com
authors: Sreedasyam
authors: S
authors: Ravinder
authors: Akula Tukaram
authors: AT
authors: Bapuji
authors: Khagga
authors: K
authors: Mukkanti
authors: Datla Rama
authors: DR
authors: Raju
authors: Hamsa Laxmi Venkata
authors: HL
authors: Ravikiran
authors: Dendhi Chandrapal
authors: DC
authors: Reddy
mesh_terms: D000328:Adult; D000068180:Aripiprazole; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D008297:Male; D010879:Piperazines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015363:Quinolones / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D052616:Solid Phase Extraction; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole