Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
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 be...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin
2015
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/43812/ http://irep.iium.edu.my/43812/ http://irep.iium.edu.my/43812/1/TJPR_Amlodipine_2015.pdf |
| Summary: | 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. |
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