高效液相色谱法测定氨鲁米特中m-氨鲁米特含量

Determination of m-Aminoglutethimide, the Key Impurity in Aminoglutethimide with HPLC

目的 :采用高效液相色谱法 (HPLC)测定氨鲁米特中的杂质m 氨鲁米特的含量。方法 :色谱柱WatersSpherlsorbODS(4 .6mm× 15 0mm ,5 μm) ,流动相为醋酸盐缓冲液 (pH 5 .0 )∶甲醇 (75∶2 5 ) ,检测波长 2 40nm。 结果 :测定氨鲁米特中的杂质m 氨鲁米特的含量 <1.0 % ,线性范围 0 .0 2 5～ 0 .15 μg(n =5 ) ,r=0 .9998,平均回收率 10 0 .7% ,RSD =1.3 3 %。结论 :该法用于测定氨鲁米特中杂质m 氨鲁米特的限量检查 ,方法准确 ,重现性好 ,专属性强。

Objective:To determine the content of m aminoglutethimide, the key impurity in aminoglutethimide with an HPLC method. Methods:Chromatography was performed on a Waters Spherlsorb column (4.6 mm×150 mm, 5 μm), with a mixture of pH 5.0 acetate buffer: methanol (75∶25) as the mobile phase. The detection wavelength was 240 nm. Results:The content of m aminoglutethimide in aminoglutethimide was shown to be <1.0%. The calibration curve was linear in the range of 0.025～0.150 μg ( n =5, r =0.999 8), and the average rate of recovery was 100.7% ( n =5, RSD =1.33%). Conclusion:The method was shown to be accurate, sensitive, reliable and could be used as the limit test of m aminoglutethimide in aminoglutethimide.