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
Highlights
Amlodipine, 2-[(2-Aminoethoxy)methyl]-4-(2chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylic acid 3-ethyl 5-methyl ester, a third generation dihydropyridine calcium antagonist
The developed method was validated according to International Conference of Harmonization (ICH) guidelines [19] to ensure specificity, linearity, range, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ) and robustness of the method
A volume of 9 ml of 0.1 M hydrochloric acid solution was added to 1 ml of amlodipine standard stock solution or to 1 ml of tablet stock solution
Summary
Amlodipine, 2-[(2-Aminoethoxy)methyl]-4-(2chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylic acid 3-ethyl 5-methyl ester, a third generation dihydropyridine calcium antagonist. It is used in the treatment of hypertension and coronary artery disease (CAD). Such as chronic stable angina, vasospastic angina (Prinzmetal’s or Variant Angina) and angiographically-documented CAD [1]. It was firstly formulated by Pfizer under the brand name of Norvasc, but several generic versions are available. Amlodipine was combined with several drugs in order to enhance their activities or to combine more activities
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