Petruczynik Anna, Wroblewski Karol, Strozek Szymon, Waksmundzka-Hajnos Monika
Acta Pol Pharm. 2016 Nov;73(6):1475-1485.
The chromatographic behavior of some basic and acidic drugs was studied on Cl 8, Phenyl-Hexyl and Polar RP columns with methanol or acetonitrile as organic modifiers of aqueous mobile phases containing addition of diethylamine. Diethylamine plays a double function of silanol blocker reagent in analysis of basic drugs and ion-pair reagent in analysis of acidic drugs. Most symmetrical peaks and highest system efficiency were obtained on Phenyl-Hexyl and Polar RP columns in tested mobile phase systems compared to results obtained on C18 column. A new rapid, simple, specific and accurate reverse phase liquid chromatographic method was developed for the simultaneous determination of atorvastatin - antihyperlipidemic drug and amlodipine - calcium channel blocker in one pharmaceutical formulation. Atorvastatin is an acidic compounds while amlodipine is a basic substance. The chromatographic separation was carried out on Phenyl-Hexyl column by gradient elution mode with acetonitrile as organic modifier, acetate buffer at pH 3.5 and Q.025 M/L diethylamine. The proposed method was validated for specificity, precision, accuracy, linearity, and robustness. The linearity range of atorvastatin and amlodipine for 5 - 100 μg/mL was obtained with limits of-detection (LOD) 3.2750 gg/mL and 3.2102 μg/mL, respectively. The proposed method made use of DAD as a tool for peak identity and purity confirmation.
研究了一些碱性和酸性药物在Cl 8、苯基己基和极性反相柱上的色谱行为，流动相为含二乙胺的水相，以甲醇或乙腈作为有机改性剂。在碱性药物分析中，二乙胺起到硅醇封端剂的作用；在酸性药物分析中，二乙胺起到离子对试剂的作用。与在C18柱上获得的结果相比，在测试的流动相体系中，苯基己基柱和极性反相柱上获得了最对称的峰和最高的系统效率。建立了一种快速、简便、特异、准确的反相液相色谱法，用于同时测定一种药物制剂中的阿托伐他汀（一种抗高血脂药物）和氨氯地平（一种钙通道阻滞剂）。阿托伐他汀是酸性化合物，而氨氯地平是碱性物质。色谱分离在苯基己基柱上采用梯度洗脱模式进行，以乙腈为有机改性剂，pH 3.5的醋酸盐缓冲液和0.025 M/L二乙胺。该方法在特异性、精密度、准确度、线性和稳健性方面得到了验证。阿托伐他汀和氨氯地平的线性范围为5 - 100 μg/mL，检测限（LOD）分别为3.2750 μg/mL和3.2102 μg/mL。该方法使用二极管阵列检测器（DAD）进行峰识别和纯度确认。
