A creative, very sensitive and noncomplicated spectrofluorimetric technique was established and further validated to determine tranexamic acid in both its authentic form and its pharmaceutical preparation dosage forms. In the introduced technique, a reaction was found between the aliphatic primary amino group of tranexamic acid and ninhydrin/phenylacetaldehyde reagents in the presence of Torell and Steinhagen buffer pH 7.0, which led to the production of a highly fluorescent product; fluorescence intensity was measured at 475 nm after excitation at 391 nm. A calibration curve was drawn with a linear range of 0.3–2 μg/ml. Limit of detection and limit of quantification values were 0.051 and 0.155 μg/ml respectively. The introduced technique was validated based on the International Council for Harmonisation guidelines and agreed for determination of tranexamic acid in its pharmaceutical formulation. Finally, this simple method was also applied for determination of tranexamic acid in spiked human plasma.

中文翻译：

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正宗形式的氨甲环酸和药物制剂的分光荧光测定的设计和策略：应用于加标人血浆

建立并进一步验证了一种创造性的、非常灵敏且简单的荧光光谱技术，以确定其真实形式和药物制剂剂型的氨甲环酸。在引入的技术中，发现在 Torell 和 Steinhagen 缓冲液 pH 7.0 存在下，氨甲环酸的脂肪族伯氨基与茚三酮/苯乙醛试剂发生反应，从而产生高荧光产物；在 391 nm 激发后，在 475 nm 处测量荧光强度。以 0.3-2 μg/ml 的线性范围绘制校准曲线。检测限和定量限值分别为 0.051 和 0.155 μg/ml。引入的技术根据国际协调委员会的指导方针进行了验证，并同意测定其药物制剂中的氨甲环酸。最后，这种简单的方法也用于测定加标人血浆中的氨甲环酸。