Salama F, El-Abasawy N, Abdel Razeq S A, Ismail M M F, Fouad M M
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Nasr City, 11454 Cairo, Egypt.
J Pharm Biomed Anal. 2003 Oct 15;33(3):411-21. doi: 10.1016/s0731-7085(03)00233-4.
Spectrophotometric procedures for the determination of two irriversible proton pump inhibitors, omeprazole (OMZ) and pantoprazole (PNZ) sodium have been developed, the procedures are based on the formation of 2:1 chelates of both drugs with different metal ions. Pantoprazole sodium is quantified by a stability-indicating procedure through chelation with iron (III) in aqueous-ethanol medium to form an orange chelate picked at 455 nm. The procedure retains its accuracy in presence of up to 70% of its degradate, sulfenic acid prepared by degrading the pure drug in borate buffer of pH 8 at 37 degrees C for 5 days. The colored chelates of OMZ in ethanol are determined spectrophotometrically at 411, 339 and 523 nm using iron (III), chromium (III) and cobalt (II), respectively. Regression analysis of Beer's plots showed good correlation in the concentration range of 15-95, 10-60 and 15-150 microml(-1) of pure OMZ using iron (III), chromium (III) and cobalt (II), respectively, and in the range of 30-300 microg ml(-1) of PNZ sodium using iron (III). The limits of detection are 0.22-3.65 microml(-1) while limits of quantitation range between 0.74 and 12.17 microg ml(-1). The optimum assay conditions are investigated and the recovery of the cited drugs from their dosage forms ranges from 97.2 to 100.3%. Good values of precision are obtained, intraday R.S.D. are 0.93-1.75% and the inter day R.S.D. are 0.51-3.29%.
已开发出用于测定两种不可逆质子泵抑制剂奥美拉唑（OMZ）和泮托拉唑（PNZ）钠的分光光度法，该方法基于两种药物与不同金属离子形成2:1螯合物。泮托拉唑钠通过在水 - 乙醇介质中与铁（III）螯合形成在455 nm处有吸收的橙色螯合物的稳定性指示程序进行定量。在存在高达70%其降解产物（通过在37℃下于pH 8的硼酸盐缓冲液中降解纯药物5天制备的亚磺酸）的情况下，该程序仍保持其准确性。分别使用铁（III）、铬（III）和钴（II），在411、339和523 nm处通过分光光度法测定乙醇中OMZ的有色螯合物。使用铁（III）、铬（III）和钴（II）时，纯OMZ在浓度范围为15 - 95、10 - 60和15 - 150 μmol L⁻¹，以及使用铁（III）时泮托拉唑钠在浓度范围为30 - 300 μg mL⁻¹内，比尔定律曲线的回归分析显示出良好的相关性。检测限为0.22 - 3.65 μmol L⁻¹，而定量限在0.74至12.17 μg mL⁻¹之间。研究了最佳分析条件，所引用药物从其剂型中的回收率在97.2%至100.3%之间。获得了良好的精密度值，日内相对标准偏差为0.93 - 1.75%，日间相对标准偏差为0.51 - 3.29%。
