HPLC-RID法测定丹参注射液中果糖和葡萄糖的含量

Determination of Fructose and Glucose in Danshen Injection by HPLCRID

目的建立丹参注射液中果糖和葡萄糖的高效液相色谱示差折光检测器(HPLC-RID)分析测定方法。方法采用Hanbon Lichrospher NH2色谱柱(250×4.6mm,5μm),流动相:乙腈-水=70∶30,流速:1.0m L·min^(-1),检测器设定温度为35℃,柱温30℃。结果果糖和葡萄糖峰分离良好,果糖的线性范围为33.72μg·m L^(-1)~1079μg·m L^(-1)(r=0.9999),平均回收率为100.1%(n=6);葡萄糖的线性范围为32.22μg·m L^(-1)~1031μg·m L^(-1)(RSD=1.99%,r=1),平均回收率为100.6%(RSD=2.35%,n=6)。结论本方法具有重现性好、简便、准确等优点,可用于丹参注射液的质量控制。

OBJECTIVE To estahlish a simple and sensitive high-performance liquid chromatography coupled with refractive index detector（ HPLC-RID） method for the determination of fructose and glucose in Danshen Injection. METHODS The HPLC method was conducted on a Hanbon Lichrospher NH2column（ 250 mm × 4. 6mm,5μm） with acetonitrile-water（ 70∶ 30） as mobile phase. The flow rate was 1. 0m L·min（-1）,the refractive index detector was set at 35℃. The column temperature was 30℃. RESULTS The calibration of fructose and glucose were linear over the ranges of 33. 72μg·m L（-1） 1079μg·m L（-1）（ r = 0. 9999） and 32. 22μg·m L（-1） 1031μg·m L（-1）（ r =1） respectively,and the average recoveries were 100. 1%（ RSD = 1. 99%,n = 6） and 100. 6%（ RSD = 2. 35%,n =6） respectively. CONCLUSION The method is accurate,sample and reproducible for qualitycontrol of Danshen Injection.