Evaluation of the pharmacokinetics of the simultaneous quantification of letrozole and palbociclib in rat plasma by a developed and validated HPLC–PDA
Autor: | Adeeba Alzamil, Hatem A. Abuelizz, Mona M. Al-Shehri, Mohamed M. Hefnawy |
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Rok vydání: | 2020 |
Předmět: |
Postmenopausal women
Chromatography Chemistry Letrozole 010401 analytical chemistry General Chemistry Pharmacology Palbociclib medicine.disease 01 natural sciences 0104 chemical sciences Food and drug administration 03 medical and health sciences 0302 clinical medicine Breast cancer Pharmacokinetics 030220 oncology & carcinogenesis medicine Hplc pda medicine.drug |
Zdroj: | Acta Chromatographica. 32:170-178 |
ISSN: | 2083-5736 |
Popis: | The US Food and Drug Administration (FDA) has affirmed the use of letrozole (LTZ) combined with palbociclib (PLB) to treat breast malignant tumor growth in postmenopausal women. A straightforward and extremely sensitive reversed-phase high-performance liquid chromatography method with photodiode array detection (RP-HPLC–PDA) was created and validated for the simultaneous determination of LTZ and PLB in rat plasma. The parameters used to give the best separation were a C18 column (150 mm × 4.6 mm, 3.5 μm) as the stationary phase with an isocratic mobile phase composed of methanol–30 mM ammonium acetate at a ratio of 60:40 (v/v), pH = 5.5, a flow rate of 0.8 mL/min, and detection wavelengths of 240 and 220 nm for LTZ and PLB, respectively. The developed method was assessed by the FDA rules over a range of 10–600 ng/mL for LTZ and PLB. The mean of %recovery of LTZ and PLB extracted from rat plasma by acetonitrile-based deproteinization was 91.06 ± 2.73 and 90.30 ± 1.95%, respectively, and the limits of detection were 5 ng/mL for LTZ and 7 ng/mL for PLB in rat plasma. The mean values of Tmax and Cmax were 6 ± 0.00 h and 266.96 ± 21.23 ng/mL for LTZ and 4 ± 0.00 h and 508.75 ± 61.56 ng/mL for PBL, respectively, after intraperitoneal administration of both drugs to rats. The developed HPLC–PDA method was demonstrated to be robust and was effectively applied to study the pharmacokinetics of LTZ and PLB in rat plasma. |
Databáze: | OpenAIRE |
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