高效液相色谱法测定复方戊酸雌二醇片中戊酸雌二醇和炔诺酮的含量(英文)

Analysis of Tablets Containing Estradiol Valerate and Norethisterone by HPLC

目的 建立用高效液相色谱法测定复方制剂中戊酸雌二醇和炔诺酮含量的方法。方法 用氰基键合硅胶为固定相 ,乙腈%D水 ( 4 7∶5 3)为流动相 ,黄体酮为内标 ,UV检测波长为 2 80nm。结果 该方法回收率为戊酸雌二醇 10 0 .6 % ,RSD =0 .9% (n =9) ,炔诺酮 10 0 .2 % ,RSD =0 .8% (n =9) ;测定了三批样品 ,结果满意。结论 该法不需经复杂的样品处理 ,简便、快速 ,准确可靠 ,可作为该复方制剂的含量测定方法。

OBJECTIVE To develop a HPLC method for determination of estradiol valerate and norethisterone in compound tablets. METHOD The chromatographic system consisted of Zorbax CN column and mobile phase of MeCN H 2O (47 : 53), with a detection wavelength at 280 nm. Progesterone was as the internal standard. RESULTS The average ( n =9) recovery both for estradiol valerate and norethisterone was 100.6 % with RSD 0.9 % and 100.2 % with RSD 0.8 %, respectively. Three batches of samples were analyzed, and satisfactory results were achieved. CONCLUSION Without complicated sampling procedure, the method was simple, rapid and accurate for the assay of the components in this pharmaceutical formulation.