Determination of Content and Content Uniformity of Bisacodyl Enteric-coated Tablet by HPLC
10.6039/j.issn.1001-0408.2016.18.42
- VernacularTitle:HPLC法测定比沙可啶肠溶片的含量及含量均匀度
- Author:
Xiru ZHANG
;
Ting SUN
;
Jianguo JIANG
;
Yonghui GUO
;
Yihua ZHANG
- Publication Type:Journal Article
- Keywords:
HPLC;
Bisacodyl enteric-coated tablets;
Content;
Content uniformity
- From:
China Pharmacy
2016;27(18):2573-2574,2575
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of content and content uniformity in Bisacodyl enter-ic-coated tablet. METHODS:HPLC method was performed on the column of Agilent ZORBAX C18 with mobile phase of acetoni-trile-20 mmol/L ammonium acetate(adjusted pH to 5.0 with acetic acid)(55∶45,V/V),the detection wavelength was 265 nm,col-umn temperature was 30℃,flow rate was 1.0 ml/min,and the volume injection was 20 μl. RESULTS:The linear range of bisaco-dyl was 50-1 000 μg/ml(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.50%-101.17%(RSD=0.5%,n=9). CONCLUSIONS:The method is reproducible with high accuracy,and suitable for the quali-ty control of Bisacodyl enteric-coated tablet.