中国药房2016，Vol.27Issue(18)：2573-2574,2575,3.DOI:10.6039/j.issn.1001-0408.2016.18.42
HPLC法测定比沙可啶肠溶片的含量及含量均匀度
Determination of Content and Content Uniformity of Bisacodyl Enteric-coated Tablet by HPLC
张西如 1孙婷 1姜建国 1郭永辉 1张轶华1
作者信息
- 1. 河北省药品检验研究院，石家庄 050011
- 折叠
摘要
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.关键词
高效液相色谱法/比沙可啶肠溶片/含量/含量均匀度Key words
HPLC/Bisacodyl enteric-coated tablets/Content/Content uniformity分类
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张西如,孙婷,姜建国,郭永辉,张轶华..HPLC法测定比沙可啶肠溶片的含量及含量均匀度[J].中国药房,2016,27(18):2573-2574,2575,3.
