Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, 5000 Córdoba, Argentina.
Anal Chim Acta. 2010 Feb 5;659(1-2):159-66. doi: 10.1016/j.aca.2009.11.038. Epub 2009 Nov 20.
In this study, the effect of complex formation with triethanolamine (TEA) alone and in combination with hydroxypropyl-beta-cyclodextrin (HP-beta-CD) on the photostability of ascorbic acid was evaluated for exposure to artificial and diffuse daylight. The first-order rate constants for the photodegradation reactions were determined. The data obtained showed that these complexes strongly reduced the photodegradation process with an 11- and 35-fold increase in the photostability of ascorbic acid, depending of the ligand concentration and the irradiation source. The multicomponent complex gave a significantly better stabilization for exposure to light than TEA alone. Due to the fact that the complexation extended the exposure of ascorbic acid to light (without molecular changes), UV spectrophotometric and reversed phase high performance liquid chromatographic (HPLC) methods were developed for the quantitative determination of the vitamin in pure form and in pharmaceutical preparations. These methods were statistically validated, all the validation parameters were found to be within the acceptance range. These results demonstrate that the proposed methods are suitable for the quality control of ascorbic acid, providing simple, rapid, precise, accurate and convenient approaches for routine analysis of bulk drug and pharmaceutical formulations.
在这项研究中,评估了三乙醇胺(TEA)单独以及与羟丙基-β-环糊精(HP-β-CD)组合形成复合物对维生素 C 在人工和漫射日光下光稳定性的影响。确定了光降解反应的一级速率常数。所得数据表明,这些络合物强烈地降低了光降解过程,使维生素 C 的光稳定性提高了 11 倍和 35 倍,具体取决于配体浓度和辐射源。多组分络合物的稳定性明显优于 TEA 单独使用。由于络合作用延长了维生素 C 暴露于光线下的时间(没有分子变化),因此开发了紫外分光光度法和反相高效液相色谱法(HPLC)来定量测定纯品和药物制剂中的维生素。这些方法经过了统计学验证,所有验证参数均在可接受范围内。这些结果表明,所提出的方法适用于维生素 C 的质量控制,为常规分析原料药和药物制剂提供了简单、快速、精确、准确和方便的方法。