HPLC法测定阿伐那非对映异构体的研究  

Determination of (R)-avanafil by HPLC

作　　者：刘元芬 叶星辰 王纠 LIU Yuanfen;YE Xingchen;WANG Jiu(Jiangsu Health Vocational College,Nanjing 211800,China;Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems,Guangdong Pharmaceutical University,Guangzhou 510006,China;The Center for Drug Research and Development,Guangdong Pharmaceutical University,Guangzhou 510006,China;Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System,Guangzhou 510006,China;Guangdong Provincial Engineering Center for Modified-released Pharmaceutical Products,Guangzhou 510006,China)

机构地区：[1]江苏卫生健康职业学院,江苏南京211800 [2]广东省药物新剂型重点实验室,广东广州510006 [3]广东药科大学新药研发中心,广东广州510006 [4]广东省药物缓控释制剂工程技术研究中心,广东广州510006 [5]广东省局部精准药物递药制剂工程技术研究中心,广东广州510006

出　　处：《广东药科大学学报》2022年第3期20-24,共5页Journal of Guangdong Pharmaceutical University

基　　金：2020年江苏省中青年学术带头人培养对象项目;广东省医学科学技术研究基金(B2020033)。

摘　　要：目的 建立HPLC法检测阿伐那非原料药中的对映异构体。方法 采用CHIRALCEL OD-H色谱柱,以正己烷-乙醇(体积比82∶18)为流动相,流速为1.0 mL/min,检测波长为233 nm,柱温为25℃,进样量为20μL。结果 阿伐那非对映异构体与阿伐那非等其他成分达到较好分离,质量浓度在0.10~6.03μg/mL范围内与峰面积成线性相关,定量限为0.10μg/mL(相当于样品浓度的0.02%),检测限为0.033μg/mL(相当于样品浓度的0.01%),回收率在97.21%~100.41%范围内(RSD均小于1.0%);6批自制样品中均未检测出阿伐那非对映异构体。结论 建立的方法准确可靠、专属性强、结果稳定、重复性好,可适用于阿伐那非对映异构体的检测和限度控制。Objective To establish an HPLC method for the determination of(R)-avanafil(the enantiomer of avanafil). Methods The method was carried on a CHIRALCEL OD-H chromatographic column;n-hexane-ethanol(82∶18) was used as mobile phase at a flow rate of 1.0 mL/min, the detection wavelength was 233 nm, column temperature was 25 ℃, and injection volume was 20 μL. Results The enantiomer of avanafil was well separated from other components such as avanafil. When the isomer concentration was between 0.10-6.03 μg/mL, the linearity of the determination was good. The limits of quantification of the avanafil enantiomer was 0.10 μg/mL,which was equivalent to 0.02% of the sample concentration. The detection limit was 0.033 μg/mL, which was equivalent to 0.01% of the sample concentration. The recoveries of the samples were in 97.21%-100.41%(RSD<1.0%). No avanafil enantiomer was detected in 6 batches of samples. Conclusion This method is accurate,reliable, stable, and reproducible, which is applicable for the detection and limit control of(R)-avanafil.

关 键 词：阿伐那非 阿伐那非异构体 高效液相色谱法 

分 类 号：R927.12[医药卫生—药学]