Mohamed Alaama1,2,
ABM Helal Uddin1
,
Huda Jamilah Mohamad1,
Noor Syafawati Amiruddin1,
SA Abbas3
1Analytical and Bio-Analytical Research Laboratory, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, International Islamic University Malaysia (IIUM), Jalan Istana, Bandar Indera Mahkota, 25200 Kuantan, Pahang, Malaysia;
2Department of Food and Analytical Chemistry, Faculty of Pharmacy, Aleppo University, Aleppo, Syria;
3School of Pharmacy, Taylors University, 1 Jalan Taylor’s, 47500 Subang Jaya, Selangor Darul Ehsan, Malaysia.
For correspondence:- ABM Uddin
Email: mohdhelal@hotmail.com
Received: 4 July 2014
Accepted: 17 February 2015
Published: 26 April 2015
Citation:
Alaama M, Uddin AH, Mohamad H, Amiruddin N, Abbas S.
Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine. Trop J Pharm Res 2015; 14(4):663-669
doi:
10.4314/tjpr.v14i4.15
© 2015 The authors.
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Abstract
Purpose: To develop and validate a new sensitive and low-cost method for the analysis of amlodipine in tablet dosage form using reversed phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection.
Methods: Standards and samples were prepared by dissolving amlodipine besylate standard or amlodipine tablets in mobile phase and sonicated for 5 min. The samples were analysed by RP-HPLC equipped with quaternary pump and auto-injector. Separation was achieved using C18 column, and the mobile phase consisted of ammonium acetate buffer containing 0.02 % triethylamine TEA (pH = 4, adjusted using glacial acetic acid) and acetonitrile in the ratio 60:40 v/v. The flow rate was 1 ml/min and a UV detector was used for the detection of amlodipine at a wavelength of 248 nm. The method was validated according to International Conference of Harmonization (ICH) guidelines.
Results: The retention time for amlodipine peak was 3.44 ± 0.41 min with a total run time of 6 min. The method was linear over the range of 0.5 - 40 µg/ml with coefficient of determination (R2) of 0.999. Recovery was 98.09 - 100.19 %, and the method showed high precision and repeatability. All validated parameters were within the range of ICH requirements.
Conclusion: A new rapid sensitive and low-cost method has been developed and validated for the analysis of amlodipine in tablet dosage form.
Keywords: Amlodipine, Recovery, Repeatability, Precision, Reversed phase high performance liquid chromatography, Validation