摘要
目的 :建立阿昔洛韦软膏高效液相色谱测定方法 ,考察该制剂的稳定性。方法 :采用高效液相色谱法测定软膏中阿昔洛韦的含量 ,考察湿度、光照及温度对阿昔洛韦软膏稳定性的影响。结果 :标准曲线方程为C=9 310×10-3A +0 159 ,r=0 9999(n=6) ;线性浓度范围为0 6～19 2μg/ml ;回收率为98 51 % ,RSD=0 42 %。阿昔洛韦软膏对湿度和强光照射不敏感 ;于40℃、60℃和80℃温度下放置10d ,其标示量分别为98 36 %、98 47 %和98 26 %。结论 :建立的方法具有简便、快速和准确度高等优点 ;该制剂对强光照射不敏感 ,室温保存稳定。
OBJECTIVE:To establish a HPLC assay for determining stability of5%aciclovir ointment.METHODS:A HPLC method was used for the content determination of aciclovir in the ointment.The stablity of aciclovir ointment under humidity,light and heat was studied.RESULTS:The regression equation of aciclovir with the concentration C to the peak heights A∶C=9.310×10 -3 A+0.159,r=0.9999(n=6);the linear confine was0.6～19.2μg/ml;recovery was98.51%;RSD was0.42%.The quality and content showed no significant changes under humidity and light.The labelling amount percentages of aciclovir were98.36%,98.47%and98.26%in the test at40℃,60℃and80℃respectively.CONCLUSION:The HPLC assay is proved to be sensitive,accurate and simple.The ointment preparation has good stability in the test at40℃and under high light.
出处
《中国药房》
CAS
CSCD
2003年第3期175-176,共2页
China Pharmacy
