RP-HPLC法测定穿心莲注射液中苯甲醇的含量

Content Determination of Benzyl Alcohol in Chuanxinlian Injection by RP-HPLC

目的:建立测定穿心莲注射液中苯甲醇含量的方法。方法:采用反相高效液相色谱法。色谱柱为Kromasil C18(250mm×4.6mm,5μm),流动相为乙腈-水(35∶65),流速为0.5mL·min-1,检测波长为210nm,柱温为40℃,进样量为20μL。结果:苯甲醇检测浓度在0.595～11.900μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9999);平均加样回收率为99.0%,RSD=0.7%(n=9)。结论:本方法简便、准确、重复性好,可用于穿心莲注射液的质量控制。

OBJECTIVE：To establish a method for the content determination of benzyl alcohol in Chuanxinlian injection.METHODS：RP-HPLC method was adopted.A Kromasil C18（250 mm×4.6 mm,5 μm） column was used with acetonitrile-water（35：65）as mobile phase at the flow rate of 0.5 mL·min-1.The detection wavelength was set at 210 nm and injection volume was 20 μL.RESULTS：The linear range of benzyl alcohol was 0.595～11.900 μg·mL-1（r=0.999 9）and the average recovery was 99.0%（RSD=0.7%,n=9）.CONCLUSION：The method is simple,accurate and reproducible for the quality control of Chuanxinlian injection.