黄体酮注射液中黄体酮与羟丙基-β-环糊精的含量测定研究  

Study on the Determination for the Content of Progesterone and Hydroxypropyl-β-cyclodextrin in Progesterone Injection

作　　者：何鹏 杨锡辉 黄越 王旻琦 孙莉 张云林 HE Peng;YANG Xi-hui;HUANG Yue;WANG Min-qi;SUN Li;ZHANG Yun-lin(Wuhu center for Food and Drug Control,Wuhu 241006,China;Anhui Changjiang Pharmaceutical Company,Wuhu 241000,China)

机构地区：[1]芜湖市食品药品检验中心,安徽芜湖241006 [2]安徽长江药业有限公司,安徽芜湖241000

出　　处：《海峡药学》2024年第10期23-26,共4页Strait Pharmaceutical Journal

基　　金：2022年安徽省药品监督管理局科技创新项目(编号:AHYJ-KJ-202223)。

摘　　要：目的运用高效液相色谱法联用示差折光检测器(HPLC-RID)建立了黄体酮注射液中黄体酮与羟丙基-β-环糊精的含量测定方法。方法色谱柱为分子排阻色谱柱(AdvanceBio SEC 130,7.8 mm×300 mm,2.7μm),流动相为乙腈-水(20∶80),检测器为示差折光(RID),温度为40℃,柱温为35℃,流速为0.8 mL·min^(-1)。结果黄体酮、羟丙基-β-环糊精分别在0.0252~0.0757 mg·mL^(-1)、0.286~0.858 mg·mL^(-1)范围内线性关系良好(r=0.9999),黄体酮、羟丙基-β-环糊精的平均回收率分别为100.1%、100.4%,RSD分别为0.3%、0.4%(n=9)。结论建立的方法操作简便、准确可靠,可用于黄体酮注射液的质量控制。OBJECTIVE To establish a method of detecting the content of progesterone and hydroxypropyl-β-cyclodextrin in progesterone injection by high performance liquid chromatography and differential refractive index detector(HPLC-RID).METHODS The sample was separated on the size exclusion chromatograph column(AdvanceBio SEC 130,7.8 mm×300 mm,2.7μm),by using acetonitrile-water(20∶80)as the mobile phase at a flow rate of 0.8 mL·min^(-1) and at 35℃.The detector was RID and the temperature was 40℃.RESULTS The linear range of progesterone was 0.0252-0.0757 mg·mL^(-1),and of hydroxypropyl-β-cyclodextrin was 0.286-0.858 mg·mL^(-1)(r=0.9999).The average recovery rate were 100.1%and 100.4%and RSD were 0.3%and 0.4%(n=9).CONCLUSION The method is simple,feasible and reliable with accurate results,which can be used to control the quality for progesterone injection.

关 键 词：黄体酮 羟丙基-Β-环糊精 黄体酮注射液 高效液相色谱法 

分 类 号：R927[医药卫生—药学]