Development of a stability‐indicating CE assay for the determination of amlodipine enantiomers in commercial tablets

Abstract

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.

Capillary electrophoresis method for the determination of isradipine enantiomers: Stability studies and pharmaceutical formulation analysis

“…IRD was found to be photosensitive in solution, as well as all compounds of the 1,4-DHP class [31,49]. However, there was no statistically significant difference in up to 24 h of study (p40.05).…”

“…The same compound is formed when 1,4-DHP class is exposed to light [31]. At 240 min, IRD was more unstable under oxidative conditions than under acid and alkaline conditions.…”

“…Enantioseparation can be achieved using chiral selectors, which discriminate between the enantiomers by an enantioselective complexation between the enantiomers of the analyte and the chiral selector giving rise to differences in the electrophoretic mobility of the enantiomers [13,21,[23][24][25]. Different kinds of chiral selectors are currently available, such as cyclodextrins (CDs) and its derivatives [26][27][28][29][30][31], chiral crown ethers [32], proteins [33], chiral surfactants, macrocyclic antibiotics [34,35], ligand-exchange complexes [36] and polysaccharides [37]. Additionally, the CE technique allows for the easy determination of physico-chemical constants (e.g.…”

Multivariate Versus Classical Univariate Calibration Methods for Spectrofluorimetric Data: Application to Simultaneous Determination of Olmesartan Medoxamil and Amlodipine Besylate in their Combined Dosage Form

“…Several analytical methods have been reported for the determination of AML in pharmaceutical formulations and/or biological fluids. These methods include spectrophotometry [19][20][21], spectrofluorimetry [22,23], anodic stripping voltammetry [24,25], HPLC [26][27][28][29][30][31], HPTLC [32], capillary electrophoresis [33] and micellar electrokinetic chromatography [34].…”

Optimized ultrasound‐assisted extraction procedure for the analysis of opium alkaloids in papaver plants by cyclodextrin‐modified capillary electrophoresis

“…Various CD additives are used for enantioseparation [33] and to improve the resolution of some compounds [28,29]. There are some reports in the literatures about addition of CD to the BGE to improve the electrophoretic separation of various alkaloids [28,[34][35][36].…”