Content Determination of Related Substances in Alprostadil for Injection by HPLC
- VernacularTitle:HPLC法测定注射用前列地尔中有关物质的含量
- Author:
Rui DING
;
Hong JI
;
Si CHEN
;
Yiming LIU
;
Li YU
- Publication Type:Journal Article
- Keywords:
Alprostadil for injection;
Prostaglandin A1;
Prostaglandin B1;
HPLC
- From:
China Pharmacy
2007;0(29):-
- CountryChina
- Language:Chinese
-
Abstract:
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 ?L.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 ?g?mL-1(r=0.999 7) and 0.23～19.90 ?g?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.
