HPLC法测定清开灵注射液中猪去氧胆酸的含量

Content Determination of Hyodeoxycholic Acid in Qingkailing Injection by HPLC

目的建立清开灵注射液中猪去氧胆酸的含量测定方法。方法采用HPLC法,色谱柱为UltimateXB-C18(5μm,250mm×4.6mm),流动相为乙腈-水-磷酸(35∶65∶0.1),流速为1mL/min,柱温为40℃,检测波长为192nm。结果猪去氧胆酸在0.20135～1.00675mg/mL范围内线性关系良好,r=0.9996,平均加样回收率为98.25%,RSD=1.26%。结论方法准确、可靠,重复性好,可用于清开灵注射液的质量控制。

Objective To establish a method for content determination of hyodeoxycholic acid in Qingkailing Injection. Methods An UltimateXB-C18 column （5 μm, 250 mm×4.6 mm） was used with a mobile phase of acetonitril-water-phosphoric acid （35 ： 65 ： 0.1）. The flow rate was 1 mL/min. The temperature of the column was 40 ℃. The detection wavelength was 192 nm. Results There was a good linear relationship between the concentration of hyodeoxycholic acid and absorption area value in range of 0.20135-1.006 75 mg/mL, r=0.9996. The average recovery was 98.25% with RSD=1.26%. This method was accurate, credible and repeatable which can be used to control the quality of Qingkailing Injection .