Abdelfatah Rehab M, Abd Elhalim Lobna Mohammed, Darwish Hany W, Ayoub Bassam M, Tony Rehab Moussa, Gamal Mohammed
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., 62574, Beni-Suef, Egypt.
Analytical Chemistry Department, Egypt Drug Authority, 51 Wezaret Al Zeraa Street, Agouza, Giza, 12311, Egypt.
Talanta. 2024 Sep 1;277:126324. doi: 10.1016/j.talanta.2024.126324. Epub 2024 May 25.
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.
由于食品配方中的维生素易降解,其含量可能与成品中的不同。加工和储存会影响维生素含量。在本研究中,采用简单高效的稳定性指示高效液相色谱法同时测定了强力B50®薄膜包衣片中的成分。强力B50®薄膜包衣片含有硫胺素(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。使用Hypersil BDS C18色谱柱实现了合理分离。使用流动相(A)和(B),流动相(A)由0.015 M己烷磺酸钠盐+0.1%三乙胺组成,用正磷酸将pH调至(2.9),而(B)系统由乙腈组成。采用国际协调会议(ICH)参数对该方法进行验证,考察了方法的线性、准确性、选择性和稳健性。相关性高于0.99,准确度结果在97.6%至102.8%之间,除FA和BT以ng/mL计外,每种维生素的检测限和定量限(LOD和LOQ)值均以μg/mL为单位确定。LOD值在0.006至15.08μg/mL之间,而LOQ值在0.031至49.77μg/mL之间。在加速条件下进行稳定性研究并计算降解百分比。其中,VB5、VB6、FA和PB、VC以及NC是最易降解的维生素。使用现代RGB 12算法进行白度评估,将我们的方法与Sasaki等人2020年报道的旧方法进行了比较。在分析性能、实际适用性和绿色度方面,比较结果支持我们新开发的方法。此外,使用AGREE和GAPI软件评估该方法的绿色度。很明显,彩色象形图的结果证实了低危害影响,新方法更环保,AGREE评分为0.66。此外,通过蓝色适用性等级指数(BAGI)工具得出了新型高效液相色谱方法的功能和适用性,最终得分为82.5。