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目的建立黄体酮氢化可的松霜中黄体酮和氢化可的松含量测定的高效液相法。方法采用C18色谱柱,,流动相为乙腈-水(1∶1),检测波长为240nm,流速为1.0mL·min-1。结果黄体酮浓度在8.012~40.06μg·mL-1内与峰面积呈良好的线性关系(r=0.99991),平均回收率为99.56%(RSD%为1.47%)。氢化可的松浓度在59.43~138.67μg·mL-1内与峰面积呈良好的线性关系(r=0.99994),平均回收率为100.19%(RSD%为1.28%)。结论本法简便、快捷,结果准确,适用于该制剂的质量控制。
Objective To establish an HPLC method for the determination of progesterone and hydrocortisone in hydrocortisone creams. Methods C18 column was used. The mobile phase was acetonitrile-water (1: 1), the detection wavelength was 240 nm and the flow rate was 1.0 mL · min-1. Results The concentration of progesterone in the range of 8.012 ~ 40.06 μg · mL-1 showed a good linear relationship with the peak area (r = 0.99991). The average recovery was 99.56% (RSD% 1.47%). The hydrocortisone concentration ranged from 59.43 to 138.67 μg · mL-1. The average recovery was 100.19% (RSD% 1.28%). Conclusion This method is simple, rapid, accurate and suitable for the quality control of the preparation.