Attia Khalid A M, El-Abasawi Nasr M, El-Olemy Ahmed, Abdelazim Ahmed H
Al-Azhar University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, 11751 Nasr City, Cairo, Egypt.
J AOAC Int. 2018 Mar 1;101(2):394-400. doi: 10.5740/jaoacint.17-0037. Epub 2017 Aug 1.
Three UV spectrophotometric methods have been developed for the simultaneous determination of two new Food and Drug Administration-approved drugs, elbasvir (EBV) and grazoprevir (GRV), in their combined pharmaceutical dosage form. These methods include dual wavelength (DW), classic least-squares (CLS), and principal component regression (PCR). To achieve the DW method, two wavelengths were chosen for each drug in a way to ensure the difference in absorbance was zero from one drug to the other. GRV revealed equal absorbance at 351 and 315 nm, for which the distinctions in absorbance were measured for the determination of EBV. In the same way, distinctions in absorbance at 375 and 334.5 nm were measured for the determination of GRV. Alternatively, the CLS and PCR models were applied to the spectra analysis because the synchronous inclusion of many unreal wavelengths rather than using a single wavelength greatly increased the precision and predictive ability of the methods. The proposed methods were successfully applied to the assay of these drugs in their pharmaceutical formulation. The obtained results were statistically compared with manufacturing methods. The results conclude that there was no significant difference between the proposed methods and the manufacturing method with respect to accuracy and precision.
已开发出三种紫外分光光度法，用于同时测定两种新的美国食品药品监督管理局批准的药物，即复方药物剂型中的艾尔巴韦（EBV）和格拉瑞韦（GRV）。这些方法包括双波长（DW）法、经典最小二乘法（CLS）和主成分回归法（PCR）。为实现双波长法，为每种药物选择两个波长，以确保一种药物与另一种药物的吸光度差异为零。GRV在351和315nm处显示出相等的吸光度，通过测量吸光度差异来测定EBV。同样，通过测量375和334.5nm处的吸光度差异来测定GRV。另外，由于同步包含许多非真实波长而非使用单一波长极大地提高了方法的精密度和预测能力，因此将CLS和PCR模型应用于光谱分析。所提出的方法成功应用于这些药物制剂的含量测定。将所得结果与生产方法进行统计学比较。结果表明，所提出的方法与生产方法在准确度和精密度方面无显著差异。
