摘要
目的建立以HPLC法测定利福霉素钠注射液中的含量方法 ,同时与国家药品标准微生物检定法测定作了比较。方法采用高效液相色谱法测定。色谱柱:Discovery C18(250×4.6mm,5μm);流动相:0.39%磷酸二氢钠溶液(用8.5%氢氧化钠溶液调节pH值至7.5)∶乙腈=545∶455;检测波长:254nm;进样量:20μL。结果利福霉素钠注射液浓度与峰面积呈良好的线性关系,线性范围为0.0517～0.1552mg.mL-1;平均回收率为100.0%,RSD为0.81%。含量测定结果与国家药品标准微生物检定法无显著性差异。结论方法重现性、专属性良好,精密度高,定量准确可靠,可代替微生物法测定利福霉素含量,为质量检验、制剂研究提供更为快捷的方法 。
OBJECTIVE To establish a HPLC method for assay of Rifamycin sodium injection. The same time with the national drug standard microbiological assay is compared. METHODS An HPLC method was used with Discovery C18 column（250 ×4.6mm,5μm）. The mobile phase was a mixture of 0. 39% sodium dihydrogen phos- phate（ whit 8.5% sodium hydroxide solution to regulate the pH value to 7. 5 ）-acetonitrile （545：455）. The detect wavelength was set at 254nm. Injection was 20μL. RESULTS The linear range of was 0. 0517 -0. 1552mg·mL^-1 . The average recovery was 100. 0% ,RSD =0. 81%. The content determination and the national drug standard micro- biological ssay showed no significant difference. CONCLUSION This method is reproducibility, specificity, preci- sion, accurate and reliable for the assay of Rifamycin sodium injection. Can replace the microbial method for the de- termination of Rifamycin content, provides a more efficient method for quality inspection, preparation, research.
出处
《海峡药学》
2013年第7期79-81,共3页
Strait Pharmaceutical Journal
