新霉素氯己定软膏质量控制研究.docVIP

新霉素氯己定软膏质量控制研究 　　[摘要] 目的 建立新霉素氯己定软膏的质量控制方法。 方法 分别采用溴化十六烷基三甲胺（HTAB）-溴试液显色法和乙酰丙酮-对二甲氨基苯甲醛试液显色法对新霉素氯己定软膏中的醋酸氯己定和硫酸新霉素进行鉴别；采用紫外-可见分光光度法（UV）在254 nm处测定，对新霉素氯己定软膏中的醋酸氯己定进行测定；采用旋光法对新霉素氯己定软膏中的硫酸新霉素进行测定。 结果 鉴别和含量测定方法均有良好的专属性。醋酸氯己定的含量测定中，线性范围为5.02～15.06 mg/L，线性相关系数（r）为1.0000，精密度、重复性和12 h稳定性的RSD分别为0.03%、0.73%和0.11%，百分回收率在100.5%和101.1%之间；硫酸新霉素的含量测定中，线性范围为0.50～8.00 mg/L，r=0.9999，精密度和重复性的RSD分别为0.61%和0.44%，溶液在4 h内稳定，百分回收率在99.67%和100.7%之间。 结论 该方法可用于新霉素氯己定软膏的质量控制。 　　[关键词] 新霉素氯己定软膏；醋酸氯己定；硫酸新霉素；紫外分光光度法；旋光法；鉴别；含量测定 　　[中图分类号] R927.1 [文献标识码] A [文章编号] 1673-7210（2016）12（c）-0153-04 　　[Abstract] Objective To establish a quality control method for Neomycin and Chlorhexidine Ointment. Methods Chlorhexidine Acetate in Neomycin and Chlorhexidine Ointment was indentified by colorimetric method with HTAB-Br test solution as indicator， while Neomycin Sulfate was indentified by colorimetric method with acetylacetone-p-dimethylaminobenzaldehyde test solution as indicator； Chlorhexidine Acetate in Neomycin and Chlorhexidine Ointment was determined by ultraviolet spectrophotometry （UV） at 254 nm， while Neomycin Sulfate was determined by polarmetric analysis. Results The identification and determination methods showed good specificity. For the determination of Chlorhexidine Acetate， the correlation coefficient （r） was 1.0000 in the range of 5.02-15.06 mg/L， the RSD for precision， repeatability， and 12 h stability were 0.03%， 0.73% and 0.11%， respectively， and the spiked recoveries ranged from 100.5% to 101.1%. For the determination of Neomycin Sulfate， r=0.9999 in the range of 0.50-8.00 mg/L， the RSD for precision and repeatability were 0.61% and 0.44%， respectively， the solutions were stable in 4 h， and the spiked recoveries ranged from 99.67% to 100.7%. Conclusion This method can be used as the quality control method for Neomycin and Chlorhexidine Ointment. 　　[Key words] Neomycin and Chlorhexidine Ointment； Chlorhexidine Acetate； Neomycin Sulfate； Ultraviolet spectrophotometry； Polarmetric analys