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

Alaama, Mohamed and Helal Uddin, A.B.M. 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:	07 Nov 2022 11:26
URI:	http://irep.iium.edu.my/id/eprint/43812

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