Background In 2019, the FDA approved a brand-new combination of linagliptin and empagliflozin in a formulation called Glyxambi® tablets for managing type-2 diabetes mellitus. Nowadays, spectrophotometric techniques occupy the first place among their peers in terms of ease of application, friendliness to the environment, and low costs. Objective This research discusses the development of two very simple spectrophotometric protocols based on zero-order spectra for the determination of linagliptin and empagliflozin. Methods The developed protocols were the induced dual-wavelength and absorption correction protocols. Linagliptin could be determined directly at 305 nm, at which the empagliflozin spectrum was zero-crossing. Empagliflozin was determined using the developed two protocols. The induced dual-wavelength technique was developed by calculating the equality factor of linagliptin to cancel its interference. The absorption correction technique was developed by measuring the correction absorption factor. Results The concentration ranges of linagliptin and empagliflozin were (1–10) µg/mL and (3–30) µg/mL, respectively. Excellent recovery results were found in bulk, dosage form, and synthetic mixtures. Low LOD and LOQ values were obtained, indicating the high sensitivity of the protocols. The statistical student’s t-test was performed to compare the results of the applied and reported protocols, indicating no difference between them. Conclusion The proposed protocols have the advantages of being straightforward, affordable, and requiring no sophisticated manipulations, just simple mathematical calculations. The proposed protocols are acceptable for routine usage in quality control laboratories and in future research applications. Highlights Two novel univariate methods were developed for quantitative analysis of linagliptin and empagliflozin in their pharmaceutical and lab mixtures, producing satisfactory results.

中文翻译：

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基于简单数学过滤的创新紫外线方案，用于同时评估两种抗糖尿病药物的全新组合：一项比较研究

背景 2019 年，FDA 批准了一种名为 Glyxambi® 片剂的全新利格列汀和恩格列净组合，用于治疗 2 型糖尿病。如今，分光光度技术以其使用方便、环境友好、成本低廉等优点在同行中处于领先地位。目的 本研究讨论了两种基于零级光谱的非常简单的分光光度测定方案的开发，用于测定利格列汀和恩格列净。方法开发的方案是诱导双波长和吸收校正方案。利格列汀可在 305 nm 处直接测定，此时恩格列净光谱出现过零。使用开发的两种方案测定恩格列净。通过计算利格列汀的等因子，开发了诱导双波长技术，消除其干扰。吸收校正技术是通过测量校正吸收系数而开发的。结果 利格列汀和恩格列净的浓度范围分别为（1~10）μg/mL和（3~30）μg/mL。在散装、剂型和合成混合物中发现了优异的回收结果。获得了低 LOD 和 LOQ 值，表明该方案具有高灵敏度。进行统计学生的 t 检验以比较所应用和报告的方案的结果，表明它们之间没有差异。结论所提出的方案具有直接、经济实惠的优点，并且不需要复杂的操作，只需要简单的数学计算。所提出的方案对于质量控制实验室和未来研究应用的常规使用是可以接受的。亮点 开发了两种新颖的单变量方法，用于定量分析药物和实验室混合物中的利格列汀和恩格列净，产生了令人满意的结果。