Stability-Indicating LC Method for the Determination of Lacidipine in Tablets. Application to Degradation Kinetics and Content Uniformity Testing

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• 作者：Fathalla Belal ; Amina Elbrashy ; Manal Eid ; Jenny Jeehan Nasr
• 关键词：Column liquid chromatographic ; Content uniformity testing ; Stability ; indicating and degradation ; kinetics ; Lacidipine
• 刊名：Chromatographia
• 出版年：2009
• 出版时间：June, 2009
• 年：2009
• 卷：69
• 期：11-12
• 页码：1201-1209
• 全文大小：537.2 KB

文摘

A simple, stability-indicating, reversed-phase liquid chromatographic method was developed for the determination of lacidipine in the presence of its degradation products. The analysis was carried out using a 150 mm 4.6 mm i.d., 5 μm particle size Nucleodur MN-C18 column. Mobile phase containing a mixture of acetonitrile and 0.02 M phosphate buffer (70:30) at pH = 5.0 was pumped at a flow rate of 1 mL min⁻¹ with UV-detection at 254 nm. The method showed good linearity in the range of 0.06–15 μg mL⁻¹ with a limit of detection (S/N = 3) of 0.016 μg mL⁻¹ (3.5 10⁻⁸ M). The suggested method was successfully applied for the analysis of lacidipine in bulk and in commercial tablets with average recoveries of 100.19 0.81 % and 100.05 0.69 % , respectively. The results were favorably compared to those obtained by a reference method. The suggested method was utilized to investigate the kinetics of alkaline, acidic, peroxide and photo-induced degradation of the drug. The apparent first-order rate constant, half-life times and activation energies of the degradation process were calculated. The pH profile curve was derived. The proposed method was successfully applied to the content uniformity testing of tablets.