Abstract: In order to achieve the rapid detection of the effective components in the Compound Sodium Salicylate, Antipyrine and Caffeine Injection, this study focuses on utilizing the Raman spectroscopy technique with its superiority of low water interference, fingerprint recognition and focused sampling. Raman spectra of the Compound Sodium Salicylate, Antipyrine and Caffeine Injection samples were analyzed, and the results showed that the Raman spectra of injection samples were mainly composed of the Raman spectra of sodium salicylate aqueous solution, antipyrine aqueous solution and caffeine aqueous solution. According to the relationship between the Raman scattering intensity and the concentration of the corresponding component, the quantitative analysis models using the spectral characteristic peaks height or peaks area were established based on the spectral characteristic peaks at 812 cm^-1 and 1033 cm^-1 of sodium salicylate gradient solution, and the spectral characteristic peaks at 724 cm^-1 and 1005 cm^-1 of antipyrine gradient solution, respectively. Considering the mutual interference between the spectra of each component, the quantitative analysis models based on partial least squares (PLS) were established by using the spectral data of sodium salicylate gradient solution in the 745~920 cm^-1 and 1010~1060 cm^-1 region, and the spectral data of antipyrine gradient solution in the 700~750 cm^-1 and 950~1020 cm^-1 region, respectively. Then, the contents of sodium salicylate and antipyrine in 31 injection samples from different production batches of three different manufacturers were predicted by the two kinds of quantitative analysis models, and the predicted values were compared with those measured by liquid chromatography. The results showed that the predicted values were close to the measured values of liquid chromatography. Among the 31 injection samples, the predicted content of sodium salicylate was between 96.4% and 102.3% of the labeled amount, and the predicted content of antipyrine was between 98.1% and 105.8% of the labeled amount. The results all met the national drug standards. The analysis result was also consistent with the result of liquid chromatography. It is indicated that the Raman technique can be utilized as the qualitative and quantitative analysis of the components of Compound Sodium Salicylate, Antipyrine and Caffeine Injection.

Key words: Raman spectrum, compound sodium Salicylate Antipyrine and Caffeine Injection, qualitative analysis, quantitative analysis