三合激素注射液含量测定方法的研究

Content determination of tristerone injection by HPLC

目的：采用高效液相色谱（HPLC）法测定三合激素注射液的含量.方法：色谱柱为Agilent ZORBAX EclipseXDB C18柱（250 mm×4.6 mm,5μm）,流动相为甲醇-水（80∶20）,流速：1.0 ml/min,柱温：40℃,检测波长为230 nm.结果：黄体酮在25～250 μg/ml浓度范围内,与峰面积呈良好线性关系,线性方程为A=1.84×104 C＋1.22×104,平均回收率为99.00％ （n =9）,RSD为1.01％;丙酸睾酮在50～500 μg/ml浓度范围内,与峰面积呈良好线性关系,线性方程为A=1.59×104 C ＋2.25×104,平均回收率为98.18％（n =9）,RSD为0.97％;苯甲酸雌二醇在3.0～ 30.0μg/ml浓度范围内,与峰面积呈良好线性关系,线性方程为A =2.5 ×104 C-8.30 ×102,平均回收率为99.18％ （n =9）,RSD为0.54％.结论：该方法简便、精密、回收率高、重现性好,可用于三合激素注射液的含量测定.

Objective ： To establish a HPLC method to determine the content of tristerone injection. Methods ： The Agilent ZORBAX Eclipse XDB CI8 （ 250 mm×4.6 mm,5μm） column was adopted , the mobile phase was methanol -water（80： 20）, the flow rate was 1.0 ml/min, the column temperature was 40 ℃ and detecting wavelength was 230 nm. Results ： The mass concentration of progesterone in the range of 25 - 250/xg/ml（ r = 1, n = 8 ） at the detecting wavelength of 230 nm had good linear correlation with the area of the test peak, the average recovery rate was 99.00% （ n = 9, RSD was 1.01% ） ; The mass concentration of Testosterone in the range of 50 - 500 μg/ml （ r = 1, n = 8 ） had good linear correlation with the area of the test peak, the average recovery rate was 98.18% （ n = 9, RSD = 0.97% ） ; The mass concentration of estradiol benzoate in the range of 3.0 - 30.0 μg/ml（ r = 1, n = 8）had good linear correlation with the area of the test peak, the average recovery rate was 99.18% （n = 9, RSD was 0.54% ）. Conclusion： The method is simple and precise with high recovery rate, high accuracy and good reproducibility, which can be used for the determination of the content of tristerone injection.