Determination of amlodipine in pharmaceutical dosage forms by liquid chromatography and ultraviolet spectrophotometry.
A liquid chromatography (LC) method and an ultraviolet (UV) spectrophotometric method were developed and validated for quantitative determination of amlodipine in tablets and compounded capsules. The isocratic LC analyses were performed on an RP18 column using a mobile phase composed of 0.1% (v/v) ortho-phosphoric acid (pH 3.0) -acetonitrile (60 + 40, v/v) at a flow rate of 1.0 mL/min. The UV spectrophotometric method was performed at 238 nm. The analytical methods were validated according to International Conference on Harmonization Guidelines. The calibration graphs were linear [correlation coefficient (r) > 0.999] in the studied concentration range of 10-30 microg/mL for LC and 10-35 microg/mL for UV spectrophotometry. The relative standard deviation values for intraday and interday precision studies were less than 2%, and the accuracy was greater than 98% for both methods. The specificity of the LC method was proved using forced degradation. Statistical analyses showed no significant difference between the results obtained by the 2 methods. The proposed methods are precise and accurate and can be applied directly and easily to the oral pharmaceutical preparations of amlodipine.
Malesuik
Marcelo Donadel
MD
Universidade Federal de Santa Maria, Departamento de Farmácia Industrial, Santa Maria, CEP 97.119-900, RS, Brazil.
Cardoso
Simone Gonçalves
SG
Bajerski
Lisiane
L
Lanzanova
Fibele Analine
FA
D017311:Amlodipine / Q000032:analysis*; D002121:Calcium Channel Blockers / Q000032:analysis*; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D007202:Indicators and Reagents; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D002121:Calcium Channel Blockers; D002214:Capsules; D007202:Indicators and Reagents; D013607:Tablets; D017311:Amlodipine