HPLC法同时测定进口壮阳药物制剂中四种成分含量  

Simultaneous Determination of Four Components in Imported Aphrodisiac Pharmaceutical Preparations by HPLC

作　　者：王素娟 张源和 赖昌威 黄财顺 王乾蕾 WANG Su-juan;ZHANG Yuan-he;LAI Chang-wei;HUANG Cai-shun;WANG Qian-lei(Zhongshan Institute of Food and Drug Control,Zhongshan 528437,China;Quacell Biotechnology Co.,Ltd.,Zhongshan 528437,China)

机构地区：[1]中山市食品药品检验所,广东中山528437 [2]中山康海泰晟生物技术有限公司,广东中山528437

出　　处：《海峡药学》2024年第12期43-47,共5页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法同时测定壮阳药物制剂中西地那非、伐地那非、他达拉非和达泊西汀四种成分含量的方法。方法采用高效液相色谱法,分析采用Inertsil Ph-3色谱柱(3.0 mm×100 mm,5μm);0.05 mol·L^(-1)三乙胺水溶液(用磷酸调节pH值至3.0)-甲醇-乙腈(58∶25∶17)为流动相,等度洗脱;流速为0.5 mL·min^(-1);检测波长290 nm;柱温30℃;进样量2μL。结果四种成分在各自范围内线性关系良好(R^(2)≥0.9999),加样回收率94.62%~104.30%,RSD小于2.0%。结论该方法快速、稳定、准确,线性范围宽,可用于壮阳药物制剂的质量分析。OBJECTIVE To develop a high-performance liquid chromatography(HPLC)method for the simultaneous quantification of sildenafil,vardenafil,tadalafil,and dapoxetine in aphrodisiac pharmaceutical preparations.METHODS Chromatographic separation was achieved on an Inertsil Ph-3 column(3.0 mm×100 mm,5μm)using a mobile phase consisting of 0.05 mol·L^(-1) triethylamine aqueous solution(pH adjusted to 3.0 with phosphoric acid)-methanol-acetonitrile(58∶25∶17)in isocratic mode.The flow rate was set at 0.5 mL·min^(-1),and the detection wavelength was 290 nm.The column temperature was maintained at 30℃,and the injection volume was 2μL.RESULTS The four components showed good linearity within their respective ranges([WTBX]R^(2)[WTBZ]>0.9999),with sample recovery rates ranging from 94.62%-104.30%,and the RSD was less than 2.0%.CONCLUSION The proposed HPLC method is rapid,robust,and reliable,with a wide linearity range,making it suitable for the quality analysis and content determination of sildenafil,vardenafil,tadalafil,and dapoxetine in aphrodisiac pharmaceutical preparations.

关 键 词：壮阳药物制剂 HPLC 西地那非 伐地那非 他达拉非 达泊西汀 含量测定 

分 类 号：R927[医药卫生—药学]