高效液相色谱法测定复方左炔诺孕酮缓释微球注射剂药物含量的研究  

Study on the determination of compound levonorgestrel sustained release microspheres injection by HPLC

作　　者：曹星辰 郭伊霖 赵春草 潘峰 陈建兴 任福正[1] 刘岩 俸灵林 Cao Xingchen;Guo Yilin;Zhao Chuncao;Pan Feng;Chen Jianxing;Ren Fuzheng;Liu Yan;Feng Linglin(Engineering Research Center of Pharmaceutical Process Chemistry,Ministry of Education,School of Pharmacy,East China University of Science and Technology,Shanghai 200237,China)

机构地区：[1]华东理工大学药学院、制药工程与过程化学教育部工程研究中心,上海200237 [2]国家卫生健康委员会计划生育药具重点实验室、上海生殖健康药具工程技术研究中心、上海市生物医药技术研究院药物与医疗器械研究所,上海200237

出　　处：《中华生殖与避孕杂志》2024年第3期300-303,共4页Chinese Journal of Reproduction and Contraception

基　　金：国家重点研发计划(2016YFC1000902);上海市“科技创新行动计划”(22DX1900400)。

摘　　要：目的建立测定复方左炔诺孕酮缓释微球注射剂中左炔诺孕酮(levonorgestrel,LNG)和炔雌醇(ethinylestradiol,EE)含量的高效液相色谱法(high-performance liquid chromatography,HPLC)。方法采用C18色谱柱Inertsil ODS-3(4.7 mm×250 mm,5μm),流动相为乙腈-水(50∶50,V/V),流速为1.0 mL/min,柱温为35℃,检测波长为265 nm,进样量为20μL。HPLC检测方法学验证后测定微球含量。结果LNG在5.03~201.20μg/mL,EE在1.55~61.92μg/mL范围内均呈良好的线性关系(r2=0.9998),专属性、精密度、回收率、重复性、稳定性等符合要求。复方LNG缓释微球注射剂中LNG的含量是16.26%,EE的含量是2.58%。结论该HPLC测定方法简单、稳定、重现性好,可为测定复方缓释制剂中左炔诺孕酮和炔雌醇含量提供参考。Objective To establish a high-performance liquid chromatography(HPLC)for determining the content of levonorgestrel(LNG)and ethinylestradiol(EE)in compound levonorgestrel sustained-release microsphere injection.Methods C18 column Inertsil ODS-3(4.7 mm×250 mm,5μm)was used.The mobile phase was acetonitrile-water(50∶50,V/V).The flow rate was 1.0 mL/min.The column temperature was 35℃.The detection wavelength was 265 nm,and the injection amount was 20μL.The content of microspheres was determined after validation of HPLC detection methodology.Results The linear relationship was good in the range of 5.03-201.20μg/mL LNG,1.55-61.92μg/mL EE(r2=0.9998).The specificity,precision,recovery,repeatability,stability,etc,met the requirements.The content of LNG in the compound LNG sustained-release microspheres injection was 16.26%,and the content of EE was 2.58%.Conclusion This HPLC can determine the content of compound levonorgestrel sustained-release injection microspheres,and the method is simple,stable,and has good reproducibility,providing a reference for the determination of levonorgestrel and ethinylestradiol in compound sustained-release preparations.

关 键 词：左炔诺孕酮 炔雌醇 高效液相色谱法 复方缓释微球注射剂 含量测定 

分 类 号：R927.2[医药卫生—药学]