摘要
目的建立痫宁一号片质量标准。方法采用HPLC法测定痫宁一号片中苯巴比妥的含量;痫宁一号片中硼砂经甲醇提取后,在酸性非水介质中与姜黄素生成红色络合物,采用分光光度法测定其硼砂含量。结果苯巴比妥在50.8～508.0μg·ml-1范围内与峰面积呈良好的线性关系(r=0.9999);精密度的RSD为1.08%;平均回收率为98.86%,RSD为0.89%。硼砂在1～25μg·ml-1范围内与吸收度呈良好线性关系(r=0.9996),平均回收率为100.3%,RSD为1.04%。结论所建立的苯巴比妥和硼砂的含量测定方法准确、专属性强,可用于制剂的质量控制。
Objective To set up a quality standard for Xianningyihao tablets.Methods The content of phenobarbital in Xianningyihao tablets was determined by HPLC.Borax in Xianningyihao tablets was extracted by methanol followed by turmeric complexation with curcumin and then detected by spectrophotometry.Results The linear range for the content of phenobarbital was 50.8-508.0 μg · ml-1（r=0.9999）.The definition precision was 1.08%,the average recovery of phenobarbital was 98.86%,and RSD was 0.89%.The linear range for the content of borax was 1-25 μg · ml-1（r=0.9996）,the average recovery was 100.3%,and RSD was 1.04%.Conclusion This method is precise and can be applied to quality control of Xianningyihao tablets.
出处
《解放军药学学报》
CAS
2012年第4期331-333,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
