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Sci. Pharm.
Volume 82
Issue 3
10.3797/scipharm.1402-11
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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Article

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

by
Hemanth JANGALA
*,
Poonam VATS
,
Arshad Hussain KHUROO
and
Tausif MONIF
Clinical Pharmacology and Pharmacokinetics, Ranbaxy Research Laboratories, Gurgaon, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(3), 585-600; https://doi.org/10.3797/scipharm.1402-11
Submission received: 17 February 2014 / Accepted: 26 April 2014 / Published: 26 April 2014
Versions Notes

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

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MDPI and ACS Style

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. https://doi.org/10.3797/scipharm.1402-11

AMA Style

JANGALA H, VATS P, KHUROO AH, 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. Scientia Pharmaceutica. 2014; 82(3):585-600. https://doi.org/10.3797/scipharm.1402-11

Chicago/Turabian Style

JANGALA, Hemanth, Poonam VATS, Arshad Hussain KHUROO, and Tausif MONIF. 2014. "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" Scientia Pharmaceutica 82, no. 3: 585-600. https://doi.org/10.3797/scipharm.1402-11

APA Style

JANGALA, H., VATS, P., KHUROO, A. H., & MONIF, T. (2014). 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. Scientia Pharmaceutica, 82(3), 585-600. https://doi.org/10.3797/scipharm.1402-11

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