摘要
目的:建立测定药用辅料蔗糖八醋酸酯含量的方法。方法:采用高效液相色谱法。色谱柱为MG ⅡC18,流动相为乙腈一水(75:25,V/V),流速为1.0ml/min,柱温为30℃,检测波长为210nm,进样量为20gl。检测3批样品含量并与《美国药典》方法(剩余滴定法)比较。结果:蔗糖八醋酸酯检测质量浓度线性范围为1.0~10mg/ml(r=0.9999),平均回收率为100.8%,RSD为0.5%(n=3)。本法与《美国药典》法测定结果比较,后者值高约1%,估计为包含的杂质量。结论:本法操作简便、专属性强、重复性好,准确度优于《美国药典》法,能够有效控制蔗糖八醋酸酯的质量。
OBJECTIVE: To establish the method for the content determination of pharmaceutical adjuvant sucrose octaacetate. METHODS: HPLC method was adopted. The determination was performed on MG Ⅱ C1 8 column with mobile phase consisted of acetonitrile-water (75 : 25, V/V) at the flow rate of 1.0 ml/min. The column temperature was 30 ℃, and the detection wavelength was set at 210 nm. The sample size was 20 p.1. The contents of 3 batches of samples were determined, and compared with the meth- od stated in United States Pharmacopeia. RESULTS: The linear range of sucrose octaacetate was 1.0-10 mg/ml (r=0.999 9) with an average recovery of 100.8% (RSD=0.5%, n=3). The content of sucrose octaacetate determined by the method of United States Pharmacopeia was 1% above higher than this method; this value may contain the weight of impurity. CONCLUSIONS: The method is simple, specific and reproducible, and can control the quality of sucrose octaacetate effectively. The accuracy of it is bet- ter than that of United States Pharmacopeia.
出处
《中国药房》
CAS
CSCD
2014年第17期1624-1625,共2页
China Pharmacy