眼科粘弹剂中硫酸软骨素含量的测定

Determination of chondroitin sulfate content in ophthalmic viscosurgical device

目的:建立眼科粘弹剂中硫酸软骨素含量的测定方法,并进行方法学验证。方法:采用醋酸钠和氯化十六烷基吡啶将样品中的硫酸软骨素沉淀,用氯化钠溶液溶解后采用咔唑法测定硫酸软骨素的含量。结果:方法学验证结果表明,线性范围为30.07~150.34μg/ml,r为0.999 5;准确度试验的9组样品平均回收率为101.40%,RSD(n=9)为0.96%;精密度试验中,12份含量测试的平均值为102.1%,RSD(n=12)为1.22%;耐用性试验中,改变条件测得的结果与正常条件下测得的含量之比为99.9%~101.4%。结论:本研究的方法线性良好,准确度、精密度和耐用性均符合标准,可用于眼科粘弹剂中硫酸软骨素含量的检测。

Objective:To establish a method for the determination of chondroitin sulfate content in ophthalmic viscosurgical device and to conduct methodological validation.Methods:The chondroitin sulfate in the sample was precipitated by sodium acetate and cetylpyridinium chloride,and then precipitate was dissolved in sodium chloride solution and the content of chondroitin sulfate was determined by carbazole method.Results:This method had good specificity with a linear range at 30.07-150.34 mg/ml and correlation coefficient(r)0.999 5.The average recovery of the 9 groups of samples for accuracy test was 101.40%with RSD(n=9)0.96%.The average value of 12 parts of samples for precision test was 102.1%with RSD(n=12)1.22%.The ratio of the content determined under the changed condition to the content determined under normal conditions is 99.9%to 101.4%in the durability test.Conclusion:The method established in this study can be used for the determination of chondroitin sulfate content in ophthalmic viscosurgical device since its linearity,accuracy,precision and durability are in line with standards.