Development of a stability-indicating CE assay for the determination of amlodipine enantiomers in commercial tablets.
A simple, accurate, precise and sensitive method using CD for separation and stability indicating assay of enantiomers of amlodipine in the commercial tablets has been established. Several types of CD were evaluated and best results were obtained using a fused-silica capillary with phosphate running buffer (100 mM, pH 3.0) containing 5 mM hydroxypropyl-alpha-CD. The method has shown adequate separation for amlodipine enantiomers from its degradation products. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The range of quantitation for both enantiomers was 5-150 microg/mL. Intra- and inter-day RSD (n=6) was <4%. The limit of quantification that produced the requisite precision and accuracy was found to be 5 microg/mL for both enantiomers. The LOD for both enantiomers was found to be 0.5 microg/mL. Degradation products produced as a result of stress studies did not interfere with the detection of enantiomers and the assay can thus be considered stability indicating.
Fakhari
Ali Reza
AR
Department of Chemistry, Faculty of Sciences, Shahid Beheshti University, Tehran, IR Iran. a-zavareh@sbu.ac.ir
Nojavan
Saeed
S
Haghgoo
Soheila
S
Mohammadi
Ali
A
D017311:Amlodipine / Q000032:analysis* / Q000737:chemistry; D002021:Buffers; D003505:Cyclodextrins / Q000737:chemistry; D004355:Drug Stability; D019075:Electrophoresis, Capillary / Q000379:methods*; D006358:Hot Temperature; D006868:Hydrolysis; D016014:Linear Models; D010084:Oxidation-Reduction; D010782:Photolysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013237:Stereoisomerism; D013607:Tablets / Q000737:chemistry
D002021:Buffers; D003505:Cyclodextrins; D013607:Tablets; D017311:Amlodipine