Simultaneous determination of enalapril, felodipine and their degradation products in the dosage formulation by reversed-phase high-performance liquid chromatography using a Spherisorb C8 column
作者： Xue-Zhi Qin , Joe DeMarco , Dominic P. Ip
DOI: 10.1016/0021-9673(95)00349-R
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摘要: Abstract A reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of enalapril its two degradation products, enalaprilat (diacid, hydrolytic product enalapril) enalapril-DKP (cyclization enalapril); felodipine product, H152/37 (oxidation felodipine) in combined enalapril/felodipine (5 mg/5 mg) formulation. Using a Spherisorb C 8 column with CH 3 CN-0.001 M KH 2 PO 4 (pH 2) (35:65, v/v) mobile phase, these compounds were well separated from each other, also maleic acid excipients The demonstrated to be precise, accurate, specific robust. Optimization separation terms phase composition is crucial development, which discussed detail. It proposed that under experimental conditions used, retention felodipine, DKP governed by partitioning process whereas diacid both cation-exchange residual silanols.
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