ABSTRACT
OBJECTIVE: To explore the determination of pethidine hydrochloride injection by using Raman spectroscopy to realize in-site non-invasive inspection. METHODS: CLS algorithm was used to eliminate the interference of the ampoule, correlation coefficient was used for identification, and PLS algorithm was used to establish the quantitative model. Moreover, the transfer performance of the models was investigated when used on different portable Raman instruments. RESULTS: Nineteen samples of four different batches were used to verify the method. The RESULTS showed a good coincidence with reference RESULTS on both identification and quantification, and the relative deviation from HPLC method was within 5%. Meanwhile, the Raman method showed good accuracy and repeatability with relative deviation of mean and RSD value within 1% for samples from the same batch. The differences between instruments were controlled by the key index, and quantitative analysisRESULTS of 51 samples measured on three instruments all fell in the range of 90% to 110%, among which 96% fell in a more narrow range of 95% to 105%. CONCLUSION: The Raman method established in this study could be used for the in-situ non-invasive determination of pethidine hydrochloride injection.