Ayoub Bassam M
Pharmaceutical Chemistry Department, Faculty of Pharmacy, British University in Egypt (BUE), El-Sherouk City, Cairo 11837, Egypt; The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, British University in Egypt (BUE), El-Sherouk City, Cairo 11837, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2016 Nov 5;168:118-122. doi: 10.1016/j.saa.2016.06.010. Epub 2016 Jun 6.
New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.
开发并比较了新的单变量分光光度法和多变量化学计量学方法，用于同时测定恩格列净和二甲双胍，通过处理它们的零阶吸收光谱并应用于其药物制剂。采用样品富集技术提高从片剂中提取后恩格列净的浓度，以便在无需预先分离的情况下与二甲双胍同时测定。根据ICH指南，使用联立方程在2-12μgmL(-1)的浓度范围内，两种药物的验证参数均令人满意，恩格列净和二甲双胍的检测限（LOD）值分别为0.20μgmL(-1)和0.19μgmL(-1)，定量限（LOQ）值分别为0.59μgmL(-1)和0.58μgmL(-1)。而使用偏最小二乘法（PLS-2）的化学计量学方法在2-10μgmL(-1)的浓度范围内获得了最佳结果。优化验证后的方法适用于质量控制实验室，能够快速且经济地测定最近获批的药物组合捷诺达®片剂。
