摘要
目的建立测定莱博雷生片含量的高效液相色谱法,为建立其质量标准提供依据。方法采用Alltima C_(18)色谱柱(150 mm×4.6 mm,5μm),以0.1%磷酸水溶液-乙腈(40∶60)为流动相;流速1.0 mL·min^(-1);检测波长282 nm,柱温30℃。结果莱博雷生在24.90~398.4μg·mL^(-1)与峰面积成线性关系,相关系数(r)为0.9999;重复性、精密度及稳定性良好,RSD分别为0.40%、0.20%及0.40%;平均加样回收率在99.34%~100.8%,RSD在0.70%~1.3%,3份样品中莱博雷生含量分别为标示量的93.48%、93.67%和93.46%。结论该方法准确、快速、简便,可用于莱博雷生片的含量测定。
Objective To determine lemborexant content in lemborexant tablets by high performance liquid chromatography(HPLC)and help establish its quality standard.Methods An Alltima C_(18) column(150 mm×4.6 mm,5μm)was used for the separation,with 0.1%phosphoric acid solutionacetonitrile(40∶60)as the mobile phase at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 282 nm and the column temperature was 30℃.Results There was a good linearity between lemborexant and the peak area at 24.90~398.4μg·mL^(-1),with the correction coefficient(r)of 0.9999.Relative standard deviations(RSD)of repeatability,precision and stability were 0.40%,0.20%and 0.40%,respectively.The average spiked recovery was between 99.34%~100.8%with RSD of 0.70%~1.3%.The content of 3 emborexant samples was 93.48%,93.67%and 93.46%,respectively.Conclusion The method is rapid,simple,and accurate,which can be used for the content determination in lemborexant tablets.
作者
郭思瑞
徐文峰
徐硕
张闪闪
金鹏飞
GUO Si-rui;XU Wen-feng;XU Shuo;ZHANG Shan-shan;JIN Peng-fei(Department of Pharmaceutical Science,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730)
出处
《中南药学》
CAS
2023年第3期763-766,共4页
Central South Pharmacy
