RP⁃HPLC法测定黄体酮注射液中苯甲醇的含量  

Determination of benzyl alcohol in progesterone injection by RP⁃HPLC method

作　　者：李明珠 白云 张鑫月 王先友[1] LI Mingzhu;BAI Yun;ZHANG Xinyue;WANG Xianyou(School of Pharmacy Henan University,Kaifeng 475004,Henan China)

机构地区：[1]河南大学药学院,河南开封475004

出　　处：《化学研究》2021年第6期501-503,共3页Chemical Research

摘　　要：本论文建立黄体酮注射液中苯甲醇的RP⁃HPLC含量测定方法,用其测定了黄体酮注射液中苯甲醇和苯甲醛的含量。使用C18(250 mm×4.6 mm,5μm)色谱柱分离;柱温为30℃;λD=254 nm;流动相:醋酸⁃醋酸钠缓冲液(pH=3.6)与乙腈体积比为70∶30;进样量:20μL;流速为1.0 mL/min。苯甲醇在0.01~0.03μL/L的浓度范围内线性关系良好(R_(2)=0.9998),平均回收率为99.26%,RSD为1.1%(n=6);按外标对照法以峰面积计算苯甲醇的含量在1.94%~2.03%,苯甲醛相对苯甲醇的量在0.07%~0.08%,二者含量均符合药典中的限度要求。本方法干扰少、操作简便、结果准确、重复性也较好,适合黄体酮注射液中苯甲醇的含量测定。A reversed⁃phase high⁃performance liquid chromatography determination method for benzyl alcohol in progesterone injection was established in this paper,and the contents of benzyl alcohol and benzaldehyde were determined.Separation was performed in C_(18) column(250 mm×4.6 mm,5μm)at 30℃.The detection wavelength was set at 254 nm.Solution of acetate⁃sodium acetate buffer(pH=3.6)and acetonitrile(volume ratio is 70∶30)was used as mobile phase with 1.0 mL/min.Injection volume was 20μL.The linear relationship of benzyl alcohol was good(r=0.9999)at range of 0.01~0.03μL/L.Average recovery of benzyl alcohol was 99.26%,with RSD=1.1%(n=6).According to the external standard method,the content of benzyl alcohol calculated by peak area was in range from 1.94%to 2.03%,and the amount of benzaldehyde to benzyl alcohol was in range from 0.07%to 0.08%.Both contents meet the limit requirements in the Pharmacopoeia.This method was less interference,convenient,accurate and suitable for the determination of benzyl alcohol in progesterone injection.

关 键 词：黄体酮注射液 苯甲醇 反相高效液相色谱法 含量测定 

分 类 号：O657.7[理学—分析化学]