Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2018 Nov 5;204:48-54. doi: 10.1016/j.saa.2018.06.027. Epub 2018 Jun 7.
A new and simple spectrofluorimetric method was developed and validated for determination of gabapentin and pregabalin in their pure forms and pharmaceutical formulations with high sensitivity and selectivity. The proposed method was based on the formation of fluorescent products as a result of condensation reaction of investigated drugs with ninhydrin and phenyl acetaldehyde in Teorell and Stenhagen buffer medium. The fluorescent products had emission maxima at 470 nm after excitation at 375 nm. Parameters affecting the progress of the reaction and stability of the formed products were carefully investigated individually and optimized. The fluorescence-concentration plots were rectilinear over the range of 5.0-25.0 μg ml for gabapentin and 2.0-30.0 μg ml for pregabalin with excellent correlation coefficients (0.9999 for gabapentin and pregabalin). The lower detection limits were 0.45 and 0.19 μg ml for gabapentin and pregabalin, respectively. The developed method has been validated in respect to linearity, accuracy, precision, selectivity and sensitivity. In addition, the proposed method was further applied for quantitative analysis of drugs in their pharmaceutical formulations with high degree of accuracy and precision. The obtained results had an excellent agreement with the reference method, indicating no significant difference in accuracy and precision.
本文建立并验证了一种新的、简单的分光荧光法，用于高灵敏度和高选择性地测定加巴喷丁和普瑞巴林原料药及其制剂中的加巴喷丁和普瑞巴林。该方法基于在 Teorell 和 Stenhagen 缓冲介质中，研究药物与邻苯二醛和苯乙酮缩合反应形成荧光产物。在 375nm 激发下，荧光产物在 470nm 处有最大发射峰。单独仔细研究并优化了影响反应进程和形成产物稳定性的参数。在 5.0-25.0μg/ml 范围内，加巴喷丁的荧光-浓度曲线呈线性，相关系数为 0.9999；在 2.0-30.0μg/ml 范围内，普瑞巴林的荧光-浓度曲线也呈线性，相关系数为 0.9999。加巴喷丁和普瑞巴林的检测限分别为 0.45μg/ml 和 0.19μg/ml。该方法已通过线性、准确性、精密度、选择性和灵敏度验证。此外，该方法还进一步用于其药物制剂中药物的定量分析，具有很高的准确性和精密度。所得结果与参考方法具有极好的一致性，表明在准确性和精密度方面无显著差异。
