Rahman N, Kashif M
Analytical Research Laboratory, Department of Chemistry, Aligarh Muslim University, Aligarh, UP, India.
Pharmazie. 2005 Mar;60(3):197-200.
A simple and selective kinetic spectrophotometric method for the determination of pantoprazole in pharmaceutical preparations is described. The procedure is based upon a kinetic investigation of the reaction of the drug with 1-fluoro-2,4-dinitrobenzene in DMSO at room temperature. The absorbance of the coloured product was measured at 420 nm. The plot of the logarithm of the initial rate of the reaction vs. the logarithm of molar concentration of pantoprazole is linear over the range 10-20 microg x ml(-1). The procedure retains its accuracy in the presence of a large excess of its degradate, sulfenic acid, which is prepared by degradating the pure drug in borate buffer of pH 8 at room temperature for seven days. The results are validated statistically and through recovery studies. The method has been successfully applied to the determination of pantoprazole in commercial tablets. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.
本文描述了一种用于测定药物制剂中泮托拉唑的简单且选择性的动力学分光光度法。该方法基于在室温下，药物与1-氟-2,4-二硝基苯在二甲基亚砜中的反应动力学研究。在420nm处测量有色产物的吸光度。反应初始速率的对数与泮托拉唑摩尔浓度的对数的关系图在10 - 20μg x ml(-1)范围内呈线性。在存在大量过量降解产物亚磺酸的情况下，该方法仍保持其准确性，亚磺酸是通过在室温下将纯药物在pH 8的硼酸盐缓冲液中降解7天制备的。结果通过统计学验证和回收率研究进行了验证。该方法已成功应用于市售片剂中泮托拉唑的测定。结果与参考方法的统计学比较显示出极好的一致性，表明在准确性和精密度方面没有显著差异。
