由于它们容易退化,食品配方中的维生素水平可能与成品中的维生素水平不同。维生素水平会受到加工和储存的影响。在这项工作中,使用简单有效的稳定性指示HPLC方法同时估计StrongB50®薄膜包衣片剂的成分。StrongB50®薄膜包衣片剂含有硫胺素(VB1),核黄素(VB2),泛酸钙(VB5),吡哆醇(VB6),维生素C(VC),叶酸(FA),生物素(BT),肌醇(IS),烟酸(NC),对氨基苯甲酸(PB),氰钴胺(B12),酒石酸胆碱,和葡萄糖酸铁.HypersilBDSC18柱用于实现合理的分离。利用流动相(A)和(B),流动相(A)由0.015M己烷磺酸钠盐+0.1%三乙胺组成,使用正磷酸将pH调节至(2.9),而(B)系统由乙腈组成。使用国际协调会议(ICH)参数评估方法的验证,其中线性,准确度,选择性,并对该方法的鲁棒性进行了研究。相关性高于0.99,准确性结果范围为97.6至102.8%,并且以μg/mL为单位确定每种维生素的检测和定量限(LOD和LOQ)值,FA和BT除外,以ng/mL为单位。LOD值在0.006至15.08μg/mL之间,而LOQ值在0.031至49.77μg/mL的范围内。在应激条件下进行稳定性研究并计算降解百分比。Where,VB5,VB6,FA和PB,VC,和NC是最可降解的维生素。使用现代RGB12算法进行的白度评估比较了我们的方法和Sasaki等人报道的旧方法。,2020年。在分析性能方面,比较有利于我们新开发的方法,实用性和绿色性。此外,使用AGREE和GAPI软件来评估该方法的绿色性。很明显,彩色象形图的结果证实了低危险影响,并且新方法更绿色,AGREE评分为0.66。此外,通过蓝色适用性等级指数(BAGI)工具得出新型HPLC方法的功能性和适用性,最终得分为82.5.
Due to their susceptibility to degradation, vitamin levels in food formulations may differ from those found in the finished product. Vitamin levels can be impacted by processing and storage. In this work, the ingredients of Strong B50 ® film-coated tablets were estimated simultaneously using simple efficient stability indicating HPLC method. Strong B50 ® film-coated tablets contain thiamine (VB1), riboflavin (VB2), calcium pantothenate (VB5), pyridoxine (VB6), vitamin C (VC), folic acid (FA), biotin (BT), inositol (IS), niacin (NC), para-aminobenzoic acid (PB), cyanocobalamine (B12), choline bitartarate, and iron gluconate. Hypersil BDS C18 column was used for achieving reasonable separation. Mobile phases (A) and (B) were utilized, the mobile phase (A) consisted of 0.015 M Hexane sulfonic acid sodium salt + 0.1 % Triethylamine and orthophosphoric acid was used to adjust the pH to (2.9) while (B) system consisted of acetonitrile. Validation of the method was assessed using International Conference of Harmonization (ICH) parameters, where linearity, accuracy, selectivity, and robustness of the method were investigated. Correlations were above 0.99, accuracy results ranged from 97.6 to 102.8 % and limits for detection and quantitation (LOD and LOQ) values were determined for each vitamin in μg/mL except for FA and BT in ng/mL. LOD values were between 0.006 and 15.08 μg/mL while LOQ values ranged from 0.031 to 49.77 μg/mL. Stability studies were conducted under stressed conditions and degradation percentages were computed. Where, VB5, VB6, FA and PB, VC, and NC were the most degradable vitamins. Whiteness evaluation using the modern RGB 12 algorithm compared our method and the old reported one by Sasaki et al., 2020. The comparison favored our newly developed method in terms of analytical performance, practical applicability and greenness. Besides, AGREE and GAPI soft wares were used to assess the greenness of the method. It was clear that the results of colored pictograms confirm low hazardous impact and that the new method is greener with AGREE score of 0.66. Furthermore, the functionality and applicability of the novel HPLC approach were concluded via the Blue Applicability Grade Index (BAGI) tool with a final score of 82.5.