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目的建立一种运用拉曼光谱技术快速测定氨茶碱注射剂中无水茶碱和乙二胺的方法。方法采用拉曼光谱技术对3种规格的氨茶碱注射剂直接测定,分别以CLS、PLS和PCR定量模型对数据进行分析,并将无水茶碱和乙二胺的定量结果与法定方法的结果进行比较。结果 CLS定量模型测定氨茶碱注射剂中2种成分的结果较PLS和PCR定量模型法理想,其无水茶碱的回收率为98.4%,乙二胺的回收率为105.9%。其样品测定结果与法定方法测定结果基本一致。其中无水茶碱测定结果的准确度为(99.7±0.9)%,乙二胺的准确度为(96.5±5.5)%。结论本方法操作简便、快速无损,可成为注射剂快速检测的分析方法。
Objective To establish a method for the rapid determination of anhydrous theophylline and ethylenediamine in aminophylline injection by Raman spectroscopy. Methods The three kinds of aminophylline injection were directly determined by Raman spectroscopy. The data were analyzed by CLS, PLS and PCR quantitative models. The quantitative results of anhydrous theophylline and ethylenediamine were compared with those of the statutory method Compare. Results Compared with PLS and PCR, the results of CLS quantitative model for the determination of two components in aminophylline injection were ideal. The recovery rate of anhydrous theophylline was 98.4% and the recovery rate of ethylene diamine was 105.9%. The results of the determination of its samples and statutory methods are basically the same. Among them, the accuracy of anhydrous theophylline was (99.7 ± 0.9)% and that of ethylenediamine was (96.5 ± 5.5)%. Conclusion The method is simple, rapid and non-destructive, and can be used as an analytical method for the rapid detection of injections.