摘要
目的:制备己烯雌酚软膏,研究该制剂的含量测定方法。方法:按处方量制备,定性鉴别检查,含量测定采用HPLC法(卡马西平为内标),经C18色谱柱分离,流动相为甲醇水(6:4),240nm波长处紫外检测。结果:在8.0-3.2μg/mL浓度范围内,己烯雌酚和内标的峰面积比与浓度呈线性关系(r=0.9999);平均回收率为98.9%。结论:制备工艺可行,含量测定方法可靠,可用于医院制剂和质量控制。
Objective:To prepare diethylstilbestrol ointment and establish its method of quality control. Methods: The diethylstil-bestrol ointment was prepared according to prescription. The HPLC was used to detect the content at 240nm with carbamazepine as the internal standard,and C18 was used as chromatography column while methanol-water(6 : 4) as mobile phase. Results: The ratio of chromatographic peak area of diethylstilbestrol and internal standard correlated linearly with the concentration ranging from 8. 0 -32. 0μg/mL(r = . 9999). The average recovery was 98.9% and RSD was 0.33% . Conclusion: The preparation technique was practical and the determination of content was credible, and can be utilized in hospital preparation and quality control.
出处
《药学实践杂志》
CAS
2005年第2期88-90,共3页
Journal of Pharmaceutical Practice
