HPLC法测定注射用前列地尔中有关物质的含量

目的:建立以高效液相色谱法测定注射用前列地尔中有关物质前列腺素A1、前列腺素B1含量的方法。方法:色谱柱为Alltech AlltimaC18,流动相为磷酸盐缓冲液(pH=6.3)-乙腈-甲醇(70∶25∶5),检测波长为196nm,流速为1.5mL·min-1,柱温为室温,进样量为20μL。结果:前列腺素A1、前列腺素B1与主药及其它杂质分离良好,二者检测浓度线性范围分别为0.175～19.00(r=0.9997)、0.23～19.90μg·mL-1(r=0.9992);3批样品中前列腺素A1含量分别为4.7%、4.9%、4.3%,前列腺素B1含量分别为0.6%、0.8%、0.5%。结论:本方法操作简便,专属性强,可用于该制剂中有关物质的含量测定。

Content Determination of Related Substances in Alprostadil for Injection by HPLC

OBJECTIVE： To establish an HPLC method for the content determination of prostaglandin A1 and prostaglandin B1 in Alprostadil for injection.METHODS： The determination was performed on Alltech Alltima C18 column with mobile phase consisted of phosphate puffer（pH=6.3）-acetonitrile-methanol（70 ∶ 25 ∶ 5） at a flow rate of 1.5 mL· min^-1.The detection wavelength was set at 196 nm.The column temperature was set at room temperature and the injection volume was 20 μL.RESULTS： The prostaglandin A1 and prostaglandin B1 were well separated from main component and other impurities.The linear range of prostaglandin A1 and prostaglandin B1 were 0.175～19.00 μg·mL^-1（r=0.999 7） and 0.23～19.90 μg·mL^-1（r=0.999 2）.The contents of prostaglandin A1 in 3 batches of samples were 4.7%,4.9% and 4.3%,and the contents of prostaglandin B1 in 3 batches of samples were 0.6%,0.8% and 0.5% respectively.CONCLUSIONS： This method is proved to be simple,specific and suitable for the content determination of related substances in Alprostadil for injection.