Garcia Cássia V, Paim Clésio S, Steppe Martin
Universidade Federal do Rio Grande do Sul., Programa de Pós-graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Av. Ipiranga, Porto Alegre/RS CEP, Brazil.
J AOAC Int. 2004 Jul-Aug;87(4):842-6.
Rabeprazole sodium is a proton pump inhibitor that covalently binds and inactivates the gastric parietal cell proton pump (H+/K+ ATPase). Little has been published about the quantitative determination of this drug. The aim of this research was to develop a new liquid chromatographic method for quantitative determination of rabeprazole in coated tablets. The system consisted of a Hypersil Keystone Betabasic C8 column (250 x 4.6 mm, 5 microm particle size), an isocratic acetonitrile-water (35 + 65) mobile phase at a flow rate of 1.0 mL/min, and a diode array detector set at 282 nm. The following validation parameters were evaluated: linearity, precision, accuracy, specificity, detection and quantitation limits, and robustness. The method showed good linearity in the concentration range of 10-70 microg/mL. The quantitation limit was 2.43 microg/mL, and the detection limit was 0.80 microg/mL. The intra- and interday precision data showed that the method has good reproducibility (relative standard deviation = 1.03). Accuracy and robustness were also evaluated, and the results were satisfactory. The mean recovery was 101.61%. The analysis of a placebo mixture demonstrated the method is also specific.
雷贝拉唑钠是一种质子泵抑制剂，可共价结合并使胃壁细胞质子泵（H+/K+ ATP酶）失活。关于该药物的定量测定，此前发表的内容较少。本研究的目的是开发一种新的液相色谱法，用于定量测定肠溶片中的雷贝拉唑。该系统由一根Hypersil Keystone Betabasic C8柱（250×4.6 mm，粒径5微米）、以1.0 mL/分钟的流速等度洗脱的乙腈-水（35 + 65）流动相以及设定在282 nm的二极管阵列检测器组成。评估了以下验证参数：线性、精密度、准确度、特异性、检测限和定量限以及稳健性。该方法在10 - 70微克/毫升的浓度范围内显示出良好的线性。定量限为2.43微克/毫升，检测限为0.80微克/毫升。日内和日间精密度数据表明该方法具有良好的重现性（相对标准偏差 = 1.03）。还评估了准确度和稳健性，结果令人满意。平均回收率为101.61%。安慰剂混合物分析表明该方法也具有特异性。
