Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.
Department of Pharmacognosy and Pharmaceutical Chemistry, College of Pharmacy, Taibah University, Medinah, Saudi Arabia.
Luminescence. 2021 Aug;36(5):1327-1334. doi: 10.1002/bio.4068. Epub 2021 May 19.
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.
建立并进一步验证了一种创造性、非常灵敏且不复杂的荧光分光光度技术，以测定氨甲环酸的原形及其药物制剂的含量。在介绍的技术中，发现在 Torell 和 Steinhagen 缓冲液 pH 7.0 的存在下，氨甲环酸的脂肪族伯氨基与茚三酮/苯乙醛试剂之间发生反应，生成强荧光产物；在 391nm 激发下，于 475nm 处测量荧光强度。绘制了线性范围为 0.3-2μg/ml 的校准曲线。检测限和定量限分别为 0.051 和 0.155μg/ml。该方法基于国际协调理事会的指导原则进行了验证，并同意用于测定药物制剂中的氨甲环酸。最后，该简单方法还应用于测定人血浆中氨甲环酸的含量。
