Ragno Gaetano, Ioele Giuseppina, De Luca Michele, Garofalo Antonio, Grande Fedora, Risoli Antonella
Department of Pharmaceutical Sciences, University of Calabria, 87036 Rende, CS, Italy.
J Pharm Biomed Anal. 2006 Sep 11;42(1):39-45. doi: 10.1016/j.jpba.2005.11.025. Epub 2006 Jan 6.
An extensive study on the application of the "zero-crossing" technique for the analysis of a binary mixture of the photosensitive drug lacidipine and its corresponding by-product by derivative spectrophotometry is described. The technique has been compared to either conventional and recently developed UV spectrophotometric procedures, including chemometric methods. The prediction ability of the different analytical techniques has been checked by using the first-order derivative spectra of drug and photoproduct in binary mixtures. Relative advantages and drawbacks have been discussed. The zero-crossing technique suffers from several limitations, mostly ascribed to the selection of suitable signals along slopes of the spectral curve, giving rise to low accurate and precise results. The mean recovery from the zero-crossing analysis was calculated to lie in the 95.1-98.4% range for lacidipine, and 91.2-118.9% for the photoproduct. Chemometric methods showed a greater prediction ability with a 101.4-103.0% and 96.3-98.4% recovery for drug and degradation product, respectively.
本文描述了一项关于应用“过零”技术通过导数分光光度法分析光敏药物拉西地平及其相应副产物二元混合物的广泛研究。该技术已与传统的和最近开发的紫外分光光度法程序(包括化学计量学方法)进行了比较。通过使用二元混合物中药物和光产物的一阶导数光谱,检验了不同分析技术的预测能力。讨论了相对优点和缺点。过零技术存在几个局限性,主要归因于沿着光谱曲线斜率选择合适信号,导致结果的准确性和精密度较低。过零分析的平均回收率计算得出,拉西地平在95.1 - 98.4%范围内,光产物在91.2 - 118.9%范围内。化学计量学方法显示出更强的预测能力,药物和降解产物的回收率分别为101.4 - 103.0%和96.3 - 98.4%。