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Development and Analytical Validation of the Methodology for Vitamins in Tablets by Ultra-Performance Liquid Chromatography.
Journal of Chromatographic Science ( IF 1.5 ) Pub Date : 2020-01-17 , DOI: 10.1093/chromsci/bmz070
Giulio D C d'Oliveira 1 , Andréa R Chaves 1 , Caridad N Pérez 1
Affiliation  

In the present study, we developed a reliable and robust chromatographic method for the quantification of multivitamins in tablet samples by ultra-performance liquid chromatography (UPLC) with photodiode array detection. The vitamins nicotinamide, pyridoxine, riboflavin, and thiamin were analyzed and quantified in a total analysis time of 2.5 minutes, using hydrophilic interaction liquid chromatography stationary phase. Tocopherol acetate and cyanocobalamin were analyzed and quantified in a total analysis time of 2.5 minutes, using reversed-phase (RP)-UPLC. The analysis time reported here is lower than that of similar methods reported in the literature for single vitamin determination. The method linearity exhibits a good correlation coefficient (R2 = 0.998) with the relative residual standard deviation in the acceptable limit of 2.0%. The developed methods were validated, and the results demonstrated that the proposed analytical method showed to be selective, sensitive, accurate, and robust for the quantification of evaluated vitamins in multivitamin tablets. The work was fully developed in the quality control laboratory of a pharmaceutical industry in the Agroindustrial District of Anápolis (DAIA, Goiás, Brazil), where the product is manufactured.

中文翻译:

通过超高效液相色谱法开发和分析片剂中维生素的方法学。

在本研究中,我们开发了一种可靠且耐用的色谱方法,通过具有光电二极管阵列检测功能的超高效液相色谱(UPLC)定量测定片剂中的多种维生素。使用亲水相互作用液相色谱固定相,在2.5分钟的总分析时间内对维生素烟酰胺,吡ido醇,核黄素和硫胺素进行了分析和定量。使用反相(RP)-UPLC,在2.5分钟的总分析时间内对乙酸生育酚和氰钴胺素进行了分析和定量。此处报告的分析时间比文献中报告的用于单一维生素测定的类似方法的分析时间短。该方法的线性表现出良好的相关系数(R2 = 0.998),相对残留标准偏差在2.0%的可接受范围内。所开发的方法得到了验证,结果表明,所提出的分析方法对多种维生素片中所评估维生素的定量具有选择性,灵敏,准确和可靠。这项工作是在生产产品的Anápolis农业工业区(DAIA,巴西戈亚斯)的制药业质量控制实验室中全面开发的。
更新日期:2019-11-01
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