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Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine

Alaama, Mohamed and Helaluddin , Abul Bashar Mohammed and Mohamad , Huda Jamilah and Amiruddin , Noor Syafawati and SA, Abbas (2015) Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine. Tropical Journal of Pharmaceutical Research, 14 (4). pp. 663-669. ISSN 1596-9827 (O), 1596-5996 (P)

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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.

Item Type: Article (Journal)
Additional Information: 4478/43812
Uncontrolled Keywords: Amlodipine, Recovery, Repeatability, Precision, Reversed phase high performance liquid chromatography, Validation
Subjects: Q Science > QD Chemistry
R Medicine > RS Pharmacy and materia medica
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Pharmacy > Department of Pharmaceutical Chemistry
Depositing User: Dr. A. B. M. Helal Uddin
Date Deposited: 16 Jul 2015 08:00
Last Modified: 08 Nov 2017 17:33
URI: http://irep.iium.edu.my/id/eprint/43812

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