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High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma

Authorized Users Only
2007
Authors
Rakić, Anita
Miljković, Branislava
Pokrajac, Milena
Vučićević, Katarina
Article (Published version)
Metadata
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Abstract
A selective, sensitive, and simple high-performance liquid chromatographic (HPLC) method was developed for the determination of moclobemide and its two major metabolites, Ro 12-5637 and Ro 12-8095, in human plasma. Sample preparation (0.5 ml of plasma) involved solid-phase extraction (SPE) using Speedisk (R) H2O-Philic DVB columns. Separations were performed on a Waters XTerra (TM) RP18 column (5 mu m, 150 mm x 4.6 mm). The mobile phase consisted of 10 mM KH2PO4 with 1% triethylamine (pH 3.9) and acetonitrile (93:17, v/v), and a flow-rate was 1.2 ml/min. The total run time was 13 min. UV detection was performed at 240 nm. Mean absolute recoveries were >= 90% and the limit of quantification (LOQ) for all analytes was 0.02 mg/l. Calibration curves were linear (r > 0.995) over a wide range of the analyte concentrations in plasma; thus, the method is suitable for different clinical studies when large variations in the drug/metabolites concentrations are observed. During a 5-day assay valid...ation procedure the accuracy and precision were tested and proven (relative errors (RE) lt = 13%; intra-day coefficient of variation (CV) lt = 7%; inter-day CV lt = 13%). Many drugs frequently used in the target patient population were evaluated for potential interference in order method selectivity to be ensured. The assay has been used in a clinical pharmacokinetic study to assess steady-state pharmacokinetics of moclobenide and two metabolites in depressive patients on mono- and combined therapy.

Keywords:
moclobemide / metabolites / plasma / HPLC / solid-phase extraction
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2007, 43, 4, 1416-1422
Publisher:
  • Elsevier Science BV, Amsterdam

DOI: 10.1016/j.jpba.2006.10.032

ISSN: 0731-7085

PubMed: 17141442

WoS: 000245262300031

Scopus: 2-s2.0-33847237604
[ Google Scholar ]
13
16
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/948
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Rakić, Anita
AU  - Miljković, Branislava
AU  - Pokrajac, Milena
AU  - Vučićević, Katarina
PY  - 2007
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/948
AB  - A selective, sensitive, and simple high-performance liquid chromatographic (HPLC) method was developed for the determination of moclobemide and its two major metabolites, Ro 12-5637 and Ro 12-8095, in human plasma. Sample preparation (0.5 ml of plasma) involved solid-phase extraction (SPE) using Speedisk (R) H2O-Philic DVB columns. Separations were performed on a Waters XTerra (TM) RP18 column (5 mu m, 150 mm x 4.6 mm). The mobile phase consisted of 10 mM KH2PO4 with 1% triethylamine (pH 3.9) and acetonitrile (93:17, v/v), and a flow-rate was 1.2 ml/min. The total run time was 13 min. UV detection was performed at 240 nm. Mean absolute recoveries were >= 90% and the limit of quantification (LOQ) for all analytes was 0.02 mg/l. Calibration curves were linear (r > 0.995) over a wide range of the analyte concentrations in plasma; thus, the method is suitable for different clinical studies when large variations in the drug/metabolites concentrations are observed. During a 5-day assay validation procedure the accuracy and precision were tested and proven (relative errors (RE)  lt = 13%; intra-day coefficient of variation (CV)  lt = 7%; inter-day CV  lt = 13%). Many drugs frequently used in the target patient population were evaluated for potential interference in order method selectivity to be ensured. The assay has been used in a clinical pharmacokinetic study to assess steady-state pharmacokinetics of moclobenide and two metabolites in depressive patients on mono- and combined therapy.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma
VL  - 43
IS  - 4
SP  - 1416
EP  - 1422
DO  - 10.1016/j.jpba.2006.10.032
ER  - 
@article{
author = "Rakić, Anita and Miljković, Branislava and Pokrajac, Milena and Vučićević, Katarina",
year = "2007",
abstract = "A selective, sensitive, and simple high-performance liquid chromatographic (HPLC) method was developed for the determination of moclobemide and its two major metabolites, Ro 12-5637 and Ro 12-8095, in human plasma. Sample preparation (0.5 ml of plasma) involved solid-phase extraction (SPE) using Speedisk (R) H2O-Philic DVB columns. Separations were performed on a Waters XTerra (TM) RP18 column (5 mu m, 150 mm x 4.6 mm). The mobile phase consisted of 10 mM KH2PO4 with 1% triethylamine (pH 3.9) and acetonitrile (93:17, v/v), and a flow-rate was 1.2 ml/min. The total run time was 13 min. UV detection was performed at 240 nm. Mean absolute recoveries were >= 90% and the limit of quantification (LOQ) for all analytes was 0.02 mg/l. Calibration curves were linear (r > 0.995) over a wide range of the analyte concentrations in plasma; thus, the method is suitable for different clinical studies when large variations in the drug/metabolites concentrations are observed. During a 5-day assay validation procedure the accuracy and precision were tested and proven (relative errors (RE)  lt = 13%; intra-day coefficient of variation (CV)  lt = 7%; inter-day CV  lt = 13%). Many drugs frequently used in the target patient population were evaluated for potential interference in order method selectivity to be ensured. The assay has been used in a clinical pharmacokinetic study to assess steady-state pharmacokinetics of moclobenide and two metabolites in depressive patients on mono- and combined therapy.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma",
volume = "43",
number = "4",
pages = "1416-1422",
doi = "10.1016/j.jpba.2006.10.032"
}
Rakić, A., Miljković, B., Pokrajac, M.,& Vučićević, K.. (2007). High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier Science BV, Amsterdam., 43(4), 1416-1422.
https://doi.org/10.1016/j.jpba.2006.10.032
Rakić A, Miljković B, Pokrajac M, Vučićević K. High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma. in Journal of Pharmaceutical and Biomedical Analysis. 2007;43(4):1416-1422.
doi:10.1016/j.jpba.2006.10.032 .
Rakić, Anita, Miljković, Branislava, Pokrajac, Milena, Vučićević, Katarina, "High-performance liquid chromatographic method for the determination of moclobemide and its two major metabolites in human plasma" in Journal of Pharmaceutical and Biomedical Analysis, 43, no. 4 (2007):1416-1422,
https://doi.org/10.1016/j.jpba.2006.10.032 . .

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