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目的为了实现便携式拉曼光谱仪用于药品现场执法检测,本实验对盐酸哌替啶注射液的无损检测方法开展研究。方法使用拉曼光谱法结合化学计量学的方法建立定性和定量模型:其中,使用CLS算法拟合消除安瓿瓶的干扰,相关系数法建立定性模型;PLS算法建立定量模型。另外,考察了所建模型在不同便携式拉曼光谱仪上的传递。结果 4个批次19个样品对模型进行验证,定性结果与参考结果一致;定量结果相对HPLC的相对偏差在5%以内,同时,考察了同一批次不同样品Raman法的准确性和重复性,均值相对偏差、RSD值均在1%以内,说明本方法相对于HPLC准确性重复性好。通过控制仪器关键指标控制仪器台间差,51个样品3台仪器定量结果均落在90%~110%之内,其中96%落在95%~105%之内。结论拉曼光谱法可用于盐酸哌替啶注射液的现场无损检测。
Aim To achieve a portable Raman spectrometer for on-site drug detection, this study investigated the non-destructive testing of pethidine hydrochloride injection. Methods Raman spectroscopy and chemometric methods were used to establish qualitative and quantitative models. Among them, the CLS algorithm was used to eliminate the interference of ampoules and the correlation coefficient method was used to establish the qualitative model. The PLS algorithm was used to establish a quantitative model. In addition, the transfer of the model built on different portable Raman spectrometers was investigated. Results Nineteen batches of four batches were used to validate the model. The qualitative results were consistent with those of the reference data. The relative deviation of the quantitative results from the HPLC data was within 5%. Meanwhile, the accuracy and repeatability of the Raman method were evaluated. Mean relative deviation, RSD values are less than 1%, indicating that the accuracy of this method relative to HPLC repeatability. By controlling the instrument key indicators to control the difference between the instruments, the quantitative results of 51 instruments and 3 instruments fell within 90% ~ 110%, of which 96% fell within 95% ~ 105%. Conclusion Raman spectroscopy can be used on-site non-destructive testing of pethidine hydrochloride injection.