高效液相色谱法测定氢化可的松注射液的含量

目的：建立高效液相色谱法（HPLC）测定氢化可的松注射液含量的方法。方法：采用Dikma Diamonsil ^TMC18（4．6mm×150mm，5μm）色谱柱，乙腈-水（28：72）为流动相，流速1ml／min，检测波长245nm，柱温40℃。结果：氢化可的松在20～300μg／ml范围内呈良好线性关系（r=0．999 998），平均回收率为99．6％，RSD为0．47％（n=9）。结论：该方法简便，快速，准确，能满足制剂质量标准的要求。

Quantitative Determination of Hydrocortisone Injection by HPLC

Objective ： To establish an HPLC method for the determination of the content of hydrocortisone in its injection. Methods： The chromatographic system consisted of Dikma Diamonsil ^TM C18（4.6 mm × 150 mm,5 μm） column with 40℃ as the stationary phase and acetontrile-water （28： 72） as a mobile phase, the flowing rate of which was 1 ml/min. The detection wavelength was at 245 nm. Results ： The calibration curve of the area of chromatographic peaks versus the levels of hydrocortisone was linear within the range of 20 - 300 μg/ml of hydrocortisone （ r = 0.999 998） ; the mean recovery of the assay was 99.6%, and RSD 0.47% （ n = 9 ）. Conclusion ： This method is simple, rapid and accurate, being satisfactory for pharmaceutical quality control.