Study on the Determination Method for Related Substances in Bisacodyl Raw Material and Enteric-coated Tablet
10.6039/j.issn.1001-0408.2016.21.38
- VernacularTitle:比沙可啶原料药和肠溶片中有关物质测定方法研究
- Author:
Xiru ZHANG
;
Ting SUN
;
Yonghui GUO
;
Hongli LIU
;
Xiaojun HE
;
Huijuan MIAO
;
Cheng GE
- Publication Type:Journal Article
- Keywords:
HPLC;
Bisacodyl;
Raw material;
Enteric-coated tablet;
Related substances
- From:
China Pharmacy
2016;27(21):2995-2997
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of related substances in bisacodyl raw material and enteric-coated tablet. METHODS:HPLC was performed on the column of Hibar C18 with mobile phase of acetonitrile-20 mmol/L ammonium acetate (acetic acid adjust pH to 5.0)(55∶45,V/V),detection wavelength was 265 nm,flow rate was 1.0 ml/min, column temperature was 30℃,and the injection volume was 20 μl. RESULTS:The linear range of bisacodyl was 0.25-5.0 mg/ml (r=0.999 9);the limits of detection and quantification were 19-25 ng and 61-68 ng for bisacodyl and impurity A,B,C,D and E;RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 99.50%-101.00%(RSD=0.5%,n=9). CONCLUSIONS:The method is specific, sensitive and reproducible, and can be used for the determination of related substance in bisacodyl raw material and enteric-coated tablet.
