HPLC法测定醋酸泼尼松龙注射液的含量

Determination of prednisolone acetate in prednisolone acetate injection by HPLC

目的建立高效液相色谱法测定醋酸泼尼松龙注射液中醋酸泼尼松龙含量的方法。方法采用Phenomenex Luna C18（250mm×4．6mm，5μm）色谱柱，以甲醇-水（70：30）为流动相，流速为1．0mL·min^-1，检测波长为243nm。结果醋酸泼尼松龙在16．24～162．0μg·mL^-1范围内浓度与峰面积呈良好的线性关系（r=0．9999）．平均回收率为99．76％，RSD为0．71％（n=9）。结论本方法简便、快速、结果准确。重现性好。

OBJECTIVE To establish a method for determining the content of prednisolone acetate in prednisolone acetate injection by HPLC.METHODS Phenomenex Luna C18 （250mm × 4.6mm, 5μm）column was used and methanol-water（70： 30） was used as mobil phase, the flow rate was 1.0 mL· min^-1, the detecting wavelength was at 243nm. RESULTS There was a good linear relationship between the concentration of prednisolone acetate and peak area within the range of 16.24 -- 162.4μg·mL^- 1 （r = 0.9999） . The average recover was 99.76 %, with RSD = 0.71% （n = 9）. CONCLUSION The method is highly repeatable and accurate.