Chemistry Department, Faculty of Science, Cairo University, Giza, Egypt.
Drug Test Anal. 2010 Jan;2(1):28-36. doi: 10.1002/dta.82.
Two spectrophotometric procedures are suggested for the determination of three irreversible proton pump inhibitors, rabeprazole (RAB), omeprazole (OMP) and pantoprazole (PAN) in pure form and in different pharmaceutical formulations. The first method is based on the oxidation of RAB and PAN with potassium iodate in an acidic medium followed by extracting the liberated iodine with cyclohexane and measurement at λ = 520 nm. Beer's law is valid in the concentration ranges from 10-400 and 5-400 µg ml(-1) for RAB and PAN, respectively. The apparent molar absorptivities of the resulting coloured product were found to be 1.34 × 10(3) and 1.64 × 10(3) l.mol(-1). cm(-1) for RAB and PAN, respectively. The second method is based on the interaction of the basic drugs, OMP, RAB and PAN, in 1,2-dichloroethane with bromophenol blue (BPB), bromocresol green (BCG) and bromocresol purple (BCP) in the same solvent to produce stable coloured ion pairs with maximum absorbance at 385-405 nm. Regression analysis of Beer's plots showed good correlation in the concentration ranges 10-60, 10-60 and 5-40 µg ml(-1) for OMP, 10-150, 10-150 and 10-60 µg ml(-1) for RAB and 10-250, 10-150 and 10-100 µg ml(-1) for PAN with BPB, BCG and BCP reagents, respectively. The limits of detection are 0.46-7.69 µg ml(-1) and limits of quantitation range between 1.52-8.53 µg ml(-1). The optimum assay conditions were investigated and the recovery of the drugs from their dosage forms ranged from 99.33% to 100.5%. Intraday relative standard deviations (RSD) were 0.029-1.397% and the correlation coefficients ranged from 0.9992 to 1. The two methods can be applied successfully for the determination of these drugs in tablets. The results of analysis were validated statistically through recovery studies.
两种分光光度法用于测定三种不可逆质子泵抑制剂,即拉贝拉唑(RAB)、奥美拉唑(OMP)和泮托拉唑(PAN)的纯品和不同的药物制剂。第一种方法基于在酸性介质中用碘酸钾氧化 RAB 和 PAN,然后用环己烷萃取释放的碘,并在 λ = 520nm 处测量。RAB 和 PAN 的浓度范围分别为 10-400 和 5-400μgml(-1) 时,比尔定律成立。所得有色产物的表观摩尔吸光系数分别为 1.34×10(3) 和 1.64×10(3) l.mol(-1).cm(-1)。第二种方法基于碱性药物 OMP、RAB 和 PAN 在 1,2-二氯乙烷中的相互作用,与溴酚蓝(BPB)、溴甲酚绿(BCG)和溴甲酚紫(BCP)在同一溶剂中生成最大吸收波长为 385-405nm 的稳定有色离子对。比尔定律的回归分析表明,OMP 的浓度范围为 10-60、10-60 和 5-40μgml(-1),RAB 的浓度范围为 10-150、10-150 和 10-60μgml(-1),PAN 的浓度范围为 10-250、10-150 和 10-100μgml(-1),与 BPB、BCG 和 BCP 试剂分别具有良好的相关性。检测限为 0.46-7.69μgml(-1),定量范围为 1.52-8.53μgml(-1)。研究了最佳测定条件,药物从其剂型中的回收率在 99.33%-100.5%之间。日内相对标准偏差(RSD)为 0.029-1.397%,相关系数范围为 0.9992-1。这两种方法可成功应用于片剂中这些药物的测定。通过回收研究对分析结果进行了统计学验证。