高效液相色谱法测定院内制剂消痤口服液中黄芩苷的含量

Content determination of baicalin in Xiaocuo Koufuye by HPLC

目的建立高效液相色谱(HPLC)法测定消痤口服液中黄芩苷含量的方法,以控制该制剂的质量。方法色谱柱为Diamonsil^(TM)C_(18)柱(200 mm×4.6 mm,5μm),流动相为甲醇-水-磷酸(47∶53∶0.2),柱温为室温,检测波长280 nm。结果在此色谱条件下,通过D101大孔树脂、40%乙醇洗脱,可以完全分离黄芩苷;含量测定中,得黄芩苷的回归方程为Y=5×10~7X-17 571(r=0.999 9,n=5),结果表明黄芩苷在5.86~89.60μg/m L范围内线性关系良好;平均回收率为100.7%;将本品含量指标定为每毫升含黄芩以黄芩苷(C_(21)H_(18)O_(11))计,不得少于0.50 mg。结论该方法操作简便、专属性强、重现性好,可以用于控制消痤口服液的质量。

Objective To establish content test methods for baicalin in Xiaocuo Koufuye （hospital preparation） by HPLC and control its quality. Methods The samples were separated on the column of Diamonsil C18 （200 mm×4.6 mm,5μm）,which moving phase was methanol,water and phosphoric acid （47 ： 53 ： 0.2）. The column temperature was indoor temperature and the detected wave-length was at 280 nm. Results Under such condition,baicalin was separated completely by the elution of D101 macroporous resin and ethanol （40%）. The regression equation was Y= 5×10^7X-17 571 （R =0. 999 9 ,n = 5 ）, showing a good linearity in the range of 5.86 to 89.60 μg/mL. The average recovery was 100.7%. Not less than 0.50 mg/mL of baicalin （C21H18O11 ） was set as the content index. Conclusion The method is simple, specific and with good reproducibility, which can be used to control the quality of Xiaocuo Koufuye.