近红外光谱快速检测吡拉西坦注射液中吡拉西坦的含量

目的：建立吡拉西坦注射液含量测定的近红外光谱（NIR）快速分析方法。方法：按照处方自制了40批吡拉西坦注射液实验样品，收集了44批吡拉西坦注射液工业化生产样品。以高效液相色谱法测定值作为参考，运用偏最小二乘法建立近红外光谱与吡拉西坦含量的校正模型。结果：选取6800.3~5593.0 cm^-1、4663.4~4273.8 cm^-1谱段，采用Min-Max归一化方法预处理，建立吡拉西坦注射液近红外光谱定量模型。定量模型校正集的R_c²为0.9991，RMSECV为2.29；验证集样品的R_v²为0.9989，RMSEP为2.43，平均（最大）相对偏差为-0.57%（-3.16%）；t-检验结果表明，近红外光谱预测的吡拉西坦含量与参考含量无显著性差异。结论：该方法简便快速，结果准确，可用于对吡拉西坦注射液快速检测。

Objective: To establish a rapid determination method for the concentration of piracetam in piracetam injection by near-infrared spectroscopy(NIR) analytical technique. Methods: A total of 40 laboratory samples were prepared according to the formulation of piracetam injection.And 44 batches of industrial samples were collected.The chemical values of the active components in piracetam injections were determined by high-performance liquid chromatography (HPLC).The quantitative calibration models were established by NIR combined with partial least square (PLS) regression. Results: The quantitative calibration model of piracetam was established,in which the original spectra of samples were pretreated by Min-Max normalization technology,and the spectra in the range of 6800.3-5593.0 cm^-1,4663.4-4273.8 cm^-1 were chosen for analysis.And the R_c² and RMSECV of the calibration set were 0.9991 and 2.29,respectively.The R_v² and RMSEP of the validation set were 0.9989 and 2.43,respectively.And the mean (maximum) relative error was-0.57%(-3.16%).Furthermore,a paired t-test was performed to confirm that the NIR values and the reference values were not significantly different. Conclusion: The method is simple,rapid,and can be applied to rapid detection of piracetam injection.