[关键词]
[摘要]
目的 建立核磁共振法测定盐酸替扎尼定片中盐酸替扎尼定。方法 选择盐酸替扎尼定在δ 7.82~7.92处质子峰作为定量峰,马来酸在δ 6.20~6.36处的质子峰作为内标峰,使用zg90脉冲序列获取1H-qNMR图谱,采用核磁共振法测定盐酸替扎尼定片中盐酸替扎尼定,以高效液相色谱法测定结果作为参考。结果 盐酸替扎尼定在204.10~4 812.55 µg/mL呈良好线性关系。平均回收率为100.19%,RSD值为1.20%。与HPLC法测得盐酸替扎尼定片的量基本一致。结论 建立的方法测试时间短,便捷性优势明显,极大提高了盐酸替扎尼定片中盐酸替扎尼定分析测试效率。
[Key word]
[Abstract]
Objective To establish a nuclear magnetic resonance (NMR) method to determine hydrochloride tizanidine in Hydrochloride Tizanidine Tablets. Methods Spectrum peak at δ 7.82—7.92 of hydrochloride tizanidine was employed as quantitative peaks, spectrum peak at δ 6.20—6.36 of maleic acid were employed as internal standard peaks. Zg90 pulse sequence was used to obtain the 1H-qNMR spectrum. NMR method was used to determine the content of tizanidine hydrochloride in Hydrochloride Tizanidine Tablets, with the results from high-performance liquid chromatography as a reference. Results There was a linear relationship for hydrochloride tizanidine in the range of 204.10—4 812.55 μg/mL, and the average recovery rate was 100.19%, and the RSD value was 1.20%. The amount of Tizanidine Hydrochloride Tablets measured by HPLC method was basically consistent. Conclusion The established method has the advantages of short testing time and obvious convenience, greatly improving the efficiency of analyzing and testing tizanidine hydrochloride in Tizanidine Hydrochloride Tablets.
[中图分类号]
R927.2
[基金项目]
河南省科技攻关项目(232102310384); 上海市科技计划项目(21S21903400S)