CE, with Hydroxypropyl-β-Cyclodextrin as Chiral Selector, for Separation and Determination of the Enantiomers of Amlodipine in the Serum of Hypertension Patients

• Published in: Chromatographia Vol. 65; no. 9-10; pp. 575 - 579
• Main Authors: Wang, Rong, Jia, Zheng-ping, Fan, Jun-Jie, Chen, Li-Ren, Xie, Hua, Ma, Jun, Ge, Xin, Zhang, Qiang, Ao, Yan, Wang, Juan
• Format: Journal Article
• Language: English
• Published: Oxford Wiesbaden : Vieweg Verlag 01.05.2007; Springer
• Subjects: Amlodipine; Analysis; Biological and medical sciences; capillary electrophoresis; Enantioseparation; General pharmacology; hypertension; Medical sciences; Pharmacology. Drug treatments; Serum; Antianginal agent; Biological fluid; Chemical analysis; Separation; Calcium antagonist; Cardiovascular disease; Mobile phase; Blood; Chiral selector; Enantiomer; Serum; Dihydropyridine derivatives; Quantitative analysis; Human; Hypertension; Validation; Capillary electrophoresis; Oligosaccharide; Patient; Cyclodextrin; Ultraviolet detector; Enantioseparation; Optical resolution; Amlodipine; Antihypertensive agent; Inclusion compound; Blood serum
• ISSN: 0009-5893; 1612-1112
• DOI: 10.1365/s10337-007-0212-z

A capillary electrophoretic method for separation of the enantiomers of amlodipine in the serum of hypertension patients has been established and validated. The two enantiomers were separated in a fused-silica capillary with phosphate running buffer (75 mmol L-¹, pH 2.5) containing 15 mmol L-¹ hydroxypropyl-β-cyclodextrin (HP-β-CD). The effects on the separation of buffer pH and concentration, separation potential, and concentration of HP-β-CD were investigated. The range of quantitation for both enantiomers was 2.0-16.0 μg mL-¹. Intra-day and inter-day relative standard deviation (RSD; n = 5) was <10%. The limits of detection (LOD) and quantification (LOQ) of the amlodipine enantiomers, at 214 nm, were approximately 0.5 and 0.7 μg mL-¹, respectively (S/N = 3 and 10, respectively; 5-s injection). Recovery was always >85%. Results from enantiomer separation and quantification showed that concentrations of the enantiomers of amlodipine in serum from an elderly patient were higher than in serum from a young patient administered the same dose. The method was useful for determining the concentration of the enantiomers of amlodipine in hypertension patient serum and for monitoring the transition behavior of the enantiomers in humans. The method proved suitable for application to the separation of the enantiomers of amlodipine and analysis of clinical samples.