Alogliptin is an antidiabetic drug that belongs to a group called dipeptidyl peptidase‐4 enzyme inhibitors. As the drug contains a primary amino group in its structure, it readily reacts with fluorescamine in slightly alkaline medium (borate buffer, pH 8.8) to form a highly fluorescent product. Emission of this product was measured at 477 nm (λ_ex = 387 nm). The linear range between the fluorescence intensity and the drug concentration was 0.1–0.5 μg ml⁻¹ with a good correlation coefficient (0.9986). Limits of detection and quantitation were 22 and 72 ng ml⁻¹, respectively. Guidelines of the International Conference for Harmonisation were followed to validate the developed method with acceptable results. Alogliptin content was determined successfully in its commercial dosage form using the fluorescamine method with good recovery (98.60–101.26%). The method has excellent levels of accuracy and precision compared with the reported method as assessed using Student’s t‐test and Fisher’s exact test. The method was applied successfully for the content uniformity test with high recovery and low relative standard deviation.

中文翻译：

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使用荧光胺（荧光剂）的荧光光谱法测定纯片剂和片剂形式的抗糖尿病药阿格列汀：在含量均一性测试中的应用。

阿格列汀是一种抗糖尿病药物，属于二肽基肽酶-4酶抑制剂。由于该药物在其结构中包含伯氨基，因此容易与荧光胺在弱碱性介质（硼酸盐缓冲液，pH 8.8）中反应，形成高度荧光的产物。在477 nm（_λex = 387 nm）处测量到该产物的发射。荧光强度与药物浓度之间的线性范围为0.1–0.5μgml ^-1，具有良好的相关系数（0.9986）。检测和定量限分别为22和72 ng ml ^-1， 分别。遵循国际协调会议的指南，以验证所开发的方法具有可接受的结果。使用荧光胺法成功测定了其商业剂型中的阿格列汀含量，回收率高（98.60–101.26％）。与通过学生t检验和Fisher精确检验评估的报告方法相比，该方法具有极佳的准确性和精密度。该方法成功地用于含量均一性测试，回收率高，相对标准偏差低。