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Simultaneous Determination of Amlodipine, Losartan, and the Losartan Carboxylic Acid Active Metabolite in Human Plasma by LC-MS/MS
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| Author:
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CHUONG NAI, NGUYEN VAN TRUNG, TRAN LONG THAI, TRAN VIET HUNG, NGUYEN DUC TUAN
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| Abstract:
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Background: A simple, rapid, and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method has been developed and fully validated for simultaneous quantification of amlodipine and of losartan and losartan carboxylic acid as its active metabolite in human plasma. Irbesartan was used as an internal standard (IS). Methods: LC-MS/MS with an electrospray ionization (ESI) interface performed under the multiple reaction monitoring (MRM) mode was used for detection of the analytes. A simple liquid-liquid extraction was applied for extraction of analytes from human plasma after acidification with phosphoric acid using ethyl acetate as an agent. The reconstituted samples were chromatographed on a C18 column with a mixture of acetonitrile and 0.1% formic acid (65:35, v/v) as the mobile phase at a flow rate of 0.55 mL/min. A detailed validation of the method was performed in accordance with the guidelines of the US Federal Drug Administration (US-FDA) and the European Medicines Agency (EMA).
Results: The calibration curves were linear in the range of 0.045–15.000 ng/mL for amlodipine and 0.5–1000 ng/mL for losartan and losartan carboxylic acid. The results of the intra- and inter-day precision and accuracy were well within the acceptable limits. Moreover, all analytes were stable under the test conditions.
Conclusion: The validated bioanalytical method can be applied for clinical bioequivalence studies to evaluate the in vivo bioequivalence of products containing amlodipine and losartan.
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| Keyword:
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Amlodipine, losartan, LC-MS/MS, human plasma.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.282
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| Download:
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