摘要
目的:建立雷美替胺相关制剂中雷美替胺与其对映异构体的液相分析测定方法。方法:采用手性柱DAICEL AD-H(4.6 mm×250 mm,5μm)为色谱柱,以正己烷-乙醇-甲磺酸(900∶100∶0.1)为流动相,柱温为25℃,流速为1.0 mL/min,检测波长为220 nm,进样量为10μL。结果:雷美替胺与雷美替胺对映异构体分别在0.20~20.20μg/mL、0.20~19.67μg/mL浓度范围内,雷美替胺与雷美替胺对映异构体标准曲线的线性关系均良好(r>0.999),定量限均为2 ng/mL,平均回收率分别为99.00%,99.02%,RSD分别为1.01%与0.33%(n=9)。结论:该方法专属性较强,灵敏度高,稳定性好,可以为雷美替胺相关制剂中雷美替胺与其对映异构体的质量控制与有关物质研究提供参考。
Objective:To establish a method for the determination of ramelteon and its enantiomers in rametidine related preparations by liquid chromatography.Method:An DAICEL AD-H(4.6 mm×250 mm,5μm)was used,the mobile phase consisted of n-hexane-ethanol-methanesulfonic acid(900∶100∶0.1),the column temperature was 25℃,the flow rate was 1.0 mL/min,the detection wavelength was 220 nm,the sample volume was 10μL.Results:The linear relationship was good(r>0.999)in the range of 0.20~20.20μg/mL and 0.20~19.67μg/mL for ramelteon and its enantiomer,respectively.The limit of quantitation of 2 ng/mL.The average recovery was 99.00%and 99.02%,respectively.The RSD was 1.01%and 0.33%,respectively(n=9).Conclusion:This method has strong specificity,high sensitivity and good stability,which can provide reference for the quality control and related substances research of ramelteon and its enantiomer in ramelteon related preparations.
作者
张新勇
葛雪松
卓静
孙桐
Zhang Xinyong;Ge Xuesong;Zhuo Jing;Sun Tong(Suqian Institutes for Drug and Food Control,Suqian 223800,China)
出处
《山东化工》
CAS
2022年第5期126-129,共4页
Shandong Chemical Industry
