用加校正因子的主成分自身对照法测定注射用前列地尔中有关物质的含量  

Assay of the related substances in alprostadil for injection with the correction factor

作　　者：丁锐[1] 纪宏[1] 陈思[1] 刘奕明[1] 余立[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药科大学学报》2010年第5期462-466,共5页Journal of China Pharmaceutical University

基　　金：国家药典委员会<中华人民共和国药典>2010年版(二部)生化药品专业科研资助项目~~

摘　　要：建立用加校正因子的主成分自身对照法测定注射用前列地尔中有关物质的含量。采用C18色谱柱（250 mm×4.6 mm,5μm）,以0.007 mol/L磷酸盐缓冲液（pH 6.50）-乙腈-甲醇（70∶25∶5）为流动相,流速为1.5 mL/min,柱温为30℃,检测波长为196 nm,进样量为20μL。测定前列腺素A1、前列腺素B1相对于前列地尔的相对保留时间及校正因子,并计算其含量;前列地尔、前列腺素A1、前列腺素B1的质量浓度在0.125-50.0μg/mL范围内线性关系良好,r均达到0.999,杂质前列腺素A1和前列腺素B1相对于主成分前列地尔的相对保留时间分别为2.70和2.87,校正因子分别为2.296和1.681。本方法操作简便,结果准确可靠,无需提供杂质对照品,能够准确测定注射用前列地尔的有关物质。To establish a method using the correction factor for the determination of the related substance in alprostadil for injection.The assay was carried out on a C18 column（250 mm×4.6 mm,5 μm） with the mobile phase of 0.007 mol/L phosphate buffer solution（pH 6.50）-acetonitrile-methanol（70∶25∶5） at a flow rate of 1.5 mL/min.The column temperature,the detection wavelength and the injection volume were set at 30 °C,196 nm,and 20 μL,respectively.The relative retention time and the correction factor between prostaglandin A1 and alprostadil,prostaglandin B1 and alprostadil were determined.The relative retention time was used to determine the position of prostaglandin A1 and prostaglandin B1,the correction factor was used to determine the content of prostaglandin A1 and prostaglandin B1 impurities in alprostadil.Good linear relationships of alprostadil,prostaglandin A1 and prostaglandin B1 were obtained over the concentration range of 0.125-50.0 μg/mL（r=0.999）.The relative retention time between prostaglandin A1 and alprostadil was 2.70,the relative retention time between prostaglandin A1 and alprostadil was 2.87;the correction factor between prostaglandin A1 and alprostadil was 2.296;the correction factor between prostaglandin B1 and alprostadil was 1.681.This method was proved to be simple,accurate and reliable to determine the related substance of alprostadil for injection without standard substances of prostaglandin A1 and prostaglandin B1.

关 键 词：前列地尔 前列腺素A1 前列腺素B1 校正因子 

分 类 号：R927.2[医药卫生—药学]