A high-performance liquid chromatography and nuclear magnetic resonance spectroscopy-based analysis of commercially available praziquantel tablets

作者：Li Jia; Wang Yulan; Fenwick Alan; Clayton T Andrew; Lau Yu Y K; Legido Quigley Cristina; Lindon John C; Utzinger Juerg; Holmes Elaine^*

来源：Journal of Pharmaceutical and Biomedical Analysis, 2007, 45(2): 263-267.

DOI：10.1016/j.jpba.2007.06.017

• high-performance liquid chromatography
• nuclear magnetic resonance spectroscopy
• praziquantel
• principal component analysis
• quality control
• schistosomiasis

The amount of active ingredient in 20 commercially sourced batches of praziquantel (PZQ) tablets was determined using a high-performance liquid chromatography-ultraviolet (HPLC-UV) assay in conjunction with an anthentic, lot of PZQ powder. The general composition of each batch of tablets was also examined by means of H-1 nuclear magnetic resonance (NMR) spectroscopy and the NMR data were subjected to pattern recognition analysis by means of principal component analysis. The HPLC-UV results showed that each batch of PZQ tablets contained approximately the required amount of PZQ (600 mg per tablet). The NMR analysis showed a high degree of compositional variation between manufacturers, which caused by variation in excipients, along with some batch-to-batch variation in the tablets from a single manufacturer. Additionally, the PZQ tablets from one manufacturer were found to have an extra component (methyl-4-hydroxybenzoate) that was not detected in the other preparations.

• 出版日期2007-10-18