Abstract An accurate, fast and simple quantitative analysis of drug combinations with wide variation in concentration ranges has been an area of interest for several decades. The limited linearity range of UV-VIS spectroscopy may be insufficient to occupy with multiple components with diverge concentrations and several preparation steps may be required. Attenuated total reflectance Fourier transform infrared (ATR-FTIR) in combination with partial least square regression (PLSR) chemometric method can be a good alternative. Vildagliptin and metformin pharmaceutical dosage forms, which have a wide concentration ranges of (50/500, 50/850 and 50/1000 mg), were used as a model. A calibration set with partial factorial design was used to develop PLSR model able to predict the concentration of unknown samples containing the two drugs. The method was optimized, validated and successfully applied for simultaneous estimation of vildagliptin and metformin in pharmaceutical formulations with high accuracy and reproducibility. The proposed FTIR method was compared to traditional methods such as UV spectroscopy and HPLC to highlight the opportunities and challenges for every technique.

中文翻译：

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ATR-FTIR 结合化学计量学，用于量化具有不同浓度范围的药物组合中的维格列汀和二甲双胍

摘要 几十年来，对浓度范围变化很​​大的药物组合进行准确、快速和简单的定量分析一直是一个令人感兴趣的领域。UV-VIS 光谱有限的线性范围可能不足以容纳具有不同浓度的多种组分，并且可能需要几个制备步骤。衰减全反射傅里叶变换红外 (ATR-FTIR) 与偏最小二乘回归 (PLSR) 化学计量方法相结合是一个不错的选择。维格列汀和二甲双胍药物剂型具有广泛的浓度范围（50/500、50/850 和 50/1000 毫克），被用作模型。使用具有部分因子设计的校准集来开发 PLSR 模型，该模型能够预测含有两种药物的未知样品的浓度。该方法经过优化、验证并成功应用于同时评估药物制剂中维格列汀和二甲双胍的高准确度和重现性。将提议的 FTIR 方法与传统方法（如 UV 光谱和 HPLC）进行比较，以突出每种技术的机遇和挑战。