Ayoub Bassam M
The British University in Egypt, Faculty of Pharmacy, Pharmaceutical Chemistry Department, El-Sherouk City, Cairo 11837, Egypt.
J AOAC Int. 2017 Jul 1;100(4):985-991. doi: 10.5740/jaoacint.16-0285. Epub 2017 Jan 20.
Introducing green analysis to pharmaceutical products is considered a significant approach to preserving the environment. This method can be an environmentally friendly alternative to the existing methods, accompanied by a validated automated procedure for the analysis of a drug with the lowest possible number of samples. Different simple spectrophotometric methods were developed for the simultaneous determination of empagliflozin (EG) and metformin (MT) by manipulating their ratio spectra in their application on a recently approved pharmaceutical combination, Synjardy tablets. A spiking technique was used to increase the concentration of EG in samples prepared from the tablets to allow for the simultaneous determination of EG with MT without prior separation. Validation parameters according to International Conference on Harmonization guidelines were acceptable over a concentration range of 2-12 μg/mL for both drugs using derivative ratio and ratio subtraction coupled with extended ratio subtraction. The optimized methods were compared using one-way analysis of variance and proved to be suitable as ecofriendly approaches for industrial QC laboratories.
将绿色分析引入药品被认为是保护环境的一种重要方法。这种方法可以成为现有方法的一种环保替代方案，同时还伴有经过验证的自动化程序，用于以尽可能少的样品数量分析药物。通过处理恩格列净（EG）和二甲双胍（MT）在最近批准的复方制剂西格列汀二甲双胍片（Synjardy tablets）中的比例光谱，开发了不同的简单分光光度法来同时测定它们。采用加样技术提高片剂制备样品中EG的浓度，以便在无需预先分离的情况下同时测定EG和MT。根据国际协调会议指南，使用导数比、比例减法和扩展比例减法，两种药物在2-12μg/mL的浓度范围内的验证参数是可接受的。使用单向方差分析对优化后的方法进行比较，结果证明这些方法适合作为工业质量控制实验室的生态友好方法。
