Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma

Samya M. El-Gizawy, Osama H. Abdelmageed, Mahmoud A. Omar, Sayed M. Deryea, Ahmed M. Abdel-Megied

Analytical Chemistry Department, Faculty of Pharmacy, Assuit University, Assuit , Egypt..
Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 6th October City, Egypt.
Pharmaceutical Chemistry Department, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia.

DOI: 10.4236/ajac.2012.36055                

Abstract

A simple, sensitive, and specific method was developed for simultaneous determination of Amlodipine besylate (AML), Valsartan (Vals) and Hydrochlorothiazide (HCT) by high performance liquid chromatography without previous separation. Satisfactory resolution was achieved using a RP-C18 chromatographic column, Phenomenex Kinetex (150 mm × 4.6 mm i.d) and a mobile phase consisting of acetonitrile-phosphate buffer (0.05 M) with pH 2.8 in the proportion of (40/60, v/v) at a flow rate 0.8 mL/min and the wavelength detection was 227 nm. The retention time for HCT, AML and VAls was 2.26, 3.16 and 11.19 min; respectively. The described method was linear over a range of 4-28 μg /ml, 5-40 μg /ml and 1-12 μg /ml for AML, Vals and HCT; respectively. The mean percent recoveries were 99.94%, 99.96% and 99.78% for AML, Vals and HCT; respectively. F-test and t-test at 95%con?dence level were used to check the intermediate precision data obtained under different experimental setups. The method could be used for analysis of combined dose tablet formulation containing AML, Vals, HCT as well as spiked human plasma.

Keywords

Amlodipine Besylate; Valsartan; Hydrochlorothiazide;Reverse Phase High Performance Liquid Chromatography (HPLC)

Conflicts of Interest

The authors declare no conflicts of interest.

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