A simple, sensitive, and precise spectrofluorimetric method has been developed and validated for quantitation of citicoline in its pharmaceutical formulations. The proposed method based on quantitative quenching effect of citicoline on the native fluorescence of Eosin Y via developing of a binary complex reaction between the cited drug and Eosin Y in acidic medium using acetate buffer pH = 3.6. The quenching of the fluorescence of eosin was measured at 540 nm after excitation at 518 nm. Calibration graph was achieved in the range of 300-3000 ng/mL with 0.9996 as correlation coefficient and 291.0 and 93.86 ng/mL as quantitation and detection limits, respectively. The developed method considered as the first developed spectrofluorimetric one for quantitation of citicoline with high sensitivity and validated according to ICH guidelines. The selectivity of the proposed method was investigated by studying the interference of piracetam as co-formulated drug with CIT in pharmaceutical formulation, therefore the developed method could be used for routine quality control of citicoline in its pharmaceutical formulations either alone or in combination with piracetam.

中文翻译：

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分光荧光法通过曙红Y的荧光猝灭测定共吡拉西坦存在下胞磷胆碱的含量。

已经开发了一种简单，灵敏，精确的荧光光谱法，并已验证了其药物制剂中胞磷胆碱的定量方法。基于胞磷胆碱对曙红Y天然荧光定量猝灭作用的拟议方法，是通过在酸性介质中使用乙酸盐缓冲液pH = 3.6进行引证药物与曙红Y之间的二元络合物反应来进行的。在518nm激发后，在540nm处测量曙红荧光的猝灭。在300-3000 ng / mL范围内获得校正图，相关系数为0.9996，定量和检测限分别为291.0和93.86 ng / mL。该开发方法被认为是第一种开发的荧光荧光法，用于高灵敏度胞磷胆碱的定量分析，并根据ICH指南进行了验证。