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Sci. Pharm. 2014, 82(3), 585-600; doi:10.3797/scipharm.1402-11

Development and Validation of a LC-MS/MS Method for the Simultaneous Estimation of Amlodipine and Valsartan in Human Plasma: Application to a Bioequivalence Study

Clinical Pharmacology and Pharmacokinetics, Ranbaxy Research Laboratories, Gurgaon, India
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Received: 17 February 2014 / Accepted: 26 April 2014 / Published: 26 April 2014
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Abstract

A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric (LC-MS/MS) method has been developed and validated that employs solid-phase extraction for the simultaneous estimation of amlodipine and valsartan in human K3EDTA plasma using amlodipine-d4 and valsartan-d9 as internal standards. Chromatographic separation of amlodipine and valsartan was achieved on the Luna C18 (2)100A (150 x 4.6 mm, 5 μm) column using acetonitrile: 5 mM ammonium formate solution (80:20, v/v) as the mobile phase at a flow rate of 0.8 mL/min in isocratic mode. Quantification was achieved using an electrospray ion interface operating in positive mode, under multiple reaction monitoring (MRM) conditions. The assay was found to be linear over the range of 0.302–20.725 ng/mL for amlodipine and 6.062–18060.792 ng/mL for valsartan. The method has shown good reproducibility, as intra- and interday precisions were within 10% and accuracies were within 8% of nominal values for both analytes. The method was successfully applied for the bioequivalence study of amlodipine and valsartan after oral administration of a fixed dose of the combination. Additionally, as required by the current regulatory bodies, incurred sample reanalysis was performed and found to be acceptable.
Keywords: Amlodipine; Valsartan; Bioequivalence; Liquid chromatography-mass spectrometry; Non compartmental pharmacokinetics; Solid phase extraction Amlodipine; Valsartan; Bioequivalence; Liquid chromatography-mass spectrometry; Non compartmental pharmacokinetics; Solid phase extraction
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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JANGALA, H.; VATS, P.; KHUROO, A.H.; MONIF, T. Development and Validation of a LC-MS/MS Method for the Simultaneous Estimation of Amlodipine and Valsartan in Human Plasma: Application to a Bioequivalence Study. Sci. Pharm. 2014, 82, 585-600.

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