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Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study.
J Chromatogr Sci. 2012 Nov-Dec; 50(10):893-901.JC

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).

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Authors+Show Affiliations

Ravinder S
Department of Clinical Pharmacology, APL-Research Centre, Bachupally, Quthubullapur mandal, Hyderabad, AP, India. r_sreedasyam@yahoo.com
Bapuji AT
No affiliation info available
Mukkanti K
No affiliation info available
Raju DR
No affiliation info available
Ravikiran HL
No affiliation info available
Reddy DC
No affiliation info available

MeSH

AdultAripiprazoleChromatography, High Pressure LiquidDrug StabilityHumansLinear ModelsMalePiperazinesQuinolonesReproducibility of ResultsSensitivity and SpecificitySolid Phase ExtractionSpectrometry, Mass, Electrospray IonizationTandem Mass Spectrometry

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22767645

Citation

Ravinder, Sreedasyam, et al. "Development and Validation of an LC-ESI-MS Method for Quantitative Determination of Aripiprazole in Human Plasma and an Application to Pharmacokinetic Study." Journal of Chromatographic Science, vol. 50, no. 10, 2012, pp. 893-901.
Ravinder S, Bapuji AT, Mukkanti K, et al. Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study. J Chromatogr Sci. 2012;50(10):893-901.
Ravinder, S., Bapuji, A. T., Mukkanti, K., Raju, D. R., Ravikiran, H. L., & Reddy, D. C. (2012). Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study. Journal of Chromatographic Science, 50(10), 893-901. https://doi.org/10.1093/chromsci/bms087
Ravinder S, et al. Development and Validation of an LC-ESI-MS Method for Quantitative Determination of Aripiprazole in Human Plasma and an Application to Pharmacokinetic Study. J Chromatogr Sci. 2012 Nov-Dec;50(10):893-901. PubMed PMID: 22767645.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of an LC-ESI-MS method for quantitative determination of aripiprazole in human plasma and an application to pharmacokinetic study. AU - Ravinder,Sreedasyam, AU - Bapuji,Akula Tukaram, AU - Mukkanti,Khagga, AU - Raju,Datla Rama, AU - Ravikiran,Hamsa Laxmi Venkata, AU - Reddy,Dendhi Chandrapal, Y1 - 2012/07/05/ PY - 2012/7/7/entrez PY - 2012/7/7/pubmed PY - 2013/2/21/medline SP - 893 EP - 901 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 50 IS - 10 N2 - 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). SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/22767645/Development_and_validation_of_an_LC_ESI_MS_method_for_quantitative_determination_of_aripiprazole_in_human_plasma_and_an_application_to_pharmacokinetic_study_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/bms087 DB - PRIME DP - Unbound Medicine ER -