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 besyl...
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Veröffentlicht in: | Tropical journal of pharmaceutical research 2015-06, Vol.14 (4), p.663 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | 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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ISSN: | 1596-5996 1596-9827 |
DOI: | 10.4314/tjpr.v14i4.15 |