右佐匹克隆片光学异构体测定方法的改进  

Improvement of Method for Determination of Optical Isomer in Dexzopiclone Tablets

作　　者：李昭 马晓宁 彭飞城 高慧如 谭英 韩曦羽 郑金凤 刘雁鸣 石笑弋 Li Zhao;Ma Xiaoning;Peng Feicheng;Gao Huiru;Tan Ying;Han Xiyu;Zheng Jinfeng;Liu Yanming;Shi Xiaoyi(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001

出　　处：《广东化工》2024年第16期156-158,共3页Guangdong Chemical Industry

基　　金：湖南省自然科学基金部门联合基金(2024JJ8240)。

摘　　要：目的:改进HPLC法测定右佐匹克隆片中的光学异构体。方法:采用CHIRALCELOD-RH(250 mm×4.6 mm,5μm)色谱柱,流动相为0.01 mol/L磷酸氢二钠溶液(用磷酸调节pH值至5.6)-乙腈(57∶43),流速为0.5 mL/min,柱温为30℃,检测波长为305 nm,进样量为20μL。结果:阴性样品无干扰,系统适用性溶液各成分峰分离度符合要求,光学异构体浓度在0.3133μg/mL~10.0248μg/mL与峰面积线性关系良好(r=0.9999),右佐匹克隆浓度在0.3138μg/mL~10.0416μg/mL与峰面积线性关系良好(r=0.9999),光学异构体平均加样回收率为101.4%(RSD=0.75%,n=9),右佐匹克隆平均加样回收率为99.2%(RSD=1.90%,n=9),室温条件下8 h内稳定,重复性、精密度、耐用性良好。结论:改进的方法能实现右佐匹克隆片中光学异构体与相邻杂质的有效分离,提高测定结果的准确性。Objective:To improve the HPLC method for the determination of optical isomers in dexzopiclone tablets.Methods:CHIRALCELOD-RH(250 mm×4.6 mm,5μm)chromatographic column was used,the mobile phase was 0.01 mol/L dibasic sodium phosphate solution(pH adjusted to 5.6 with phosphoric acid)-acetonitrile(57∶43),the flow rate was 0.5 mL/min,the column temperature was 30℃,the detection wavelength was 305 nm,and the injection volume was 20μL.Results:There was no interference in negative samples,the peak separation degree of each component in the system suitability solution meets the requirements,the optical isomer concentration in the range of 0.3133μg/mL~10.0248μg/mL had a good linear relationship with the peak area(r=0.9999),and the dexzopiclone concentration in the range of 0.3138μg/mL~10.0416μg/mL had a good linear relationship with the peak area(r=0.9999),the average recovery of optical isomer was 101.4%(RSD=0.75%,n=9),and that of dexzopiclone was 99.2%(RSD=1.90%,n=9),Stable within 8h at room temperature,repeatability,precision and durability are good.Conclusion:The improved method can effectively separate the optical isomers from adjacent impurities in the dexzopiclone tablets and improve the accuracy of the measurement results.

关 键 词：右佐匹克隆片 光学异构体 高效液相色谱法 改进 

分 类 号：R927.1[医药卫生—药学]