摘要
目的 建立HPLC法测定比沙可啶肠溶片的含量和含量均匀度方法。方法 采用Waters Sun Fire C18（5μm,150×4.6mm）色谱柱,流动相为甲醇-水-冰醋酸（35∶65∶1）,流速：1.0m L·min-1,检测波长264nm。结果 比沙可啶在12.12μg·m L-1~121.20μg·m L-1（R=1.0000）范围内具有良好的线性,回收率为101.10%,RSD为0.91%。结论 该方法结果准确,重现性好,可用于比沙可啶肠溶片的质量控制。
OBJECTIVE To establish a HPLC method for the determination of content and content uniformity of bisacodyl enteric coated tablets. METHODS Waters SunFire C18 （5μm, 150 × 4. 6mm） column was used, mobile phase was methanol-water-acetic acid （ 35 ： 65 ： 1 ）, flow rate： 1.0mL·min-1, the detection wavelength was 264nm. RESULTS Bisacodyl within the scope of 12. 12 - 121. 20μg·mL-1 （ R=1. 0000） had a good linearity, recovery was 101.10% , RSD 0. 91%. CONCLUSION The method is accurate, reproducible, and can be used for quality control of bisacodyl coated enteric tablets.
出处
《海峡药学》
2016年第8期73-74,共2页
Strait Pharmaceutical Journal
