反相高效液相色谱法测定复方己酸羟孕酮注射液的有关物质

Determination of hydrocortisone acetate in its cream by RP-HPLC

目的：建立了HPLC法测定复方己酸羟孕酮注射液有关物质的分析方法。方法：采用Agilent HC C18柱（4．6mm×250mm，5μm）色谱柱，以甲醇-水（85：15）为流动相，检测波长225nm，流速0．7ml／min，柱温40℃。结果：己酸羟孕酮在0．2—10μg／ml（0．1％～5．0％）浓度范围内与峰面积呈良好线性关系，线性方程为Y：6．7×10^4 X-0．41，r=0．9999（n=6）；己酸羟孕酮的检出限为2ng。结论：该方法快速、简便、准确、灵敏、重现性好，并能有效地控制注射液的质量。

Objective：To establish an HPLC method for the determination of hydrocortisone acetate in its cream. Methods：An Agilent HC C18 （4.6 mm× 250 mm,5 μm）column with the ambient temperature of 40 ℃ was used as stationary phase. The solution of a mixture of acetonitrile and water （36： 64） was used as mobile phase. The flow rate of mobile phase was 1.0 ml/min and wavelength of the UV detector was at 254 nm. Results ： The liner ranges of hydrocortisone acetate was between 0. 506 μg/ml and 202.4 μg/ml （r =0. 999 9）. The average recovery of hydrocortisone acetate from its cream was 99.28% （n =9） with RSD of 0.42%. Conclusions ：This method is rapid, simple, accurate and sensitive, and it can control the quality of hydrocortisone acetate cream more effectively. This method will be adopted by CP 2010 as an official method.