甘油果糖氯化钠注射液含量测定方法的改进

发布时间：2018-08-30 08:22

【摘要】：目的:对甘油果糖氯化钠注射液中甘油、果糖、氯化钠3种成分的含量测定方法进行改进。方法:采用AgNO_3滴定法测定氯化钠的含量。采用高效液相色谱-示差折光法测定甘油和果糖的含量;色谱条件:使用5u氨基柱(250 mm×4.6 mm,5μm),以乙腈-水(75∶25)为流动相,流速1.0 mL·min~(-1),柱温35℃,流通池温度35℃。结果:氯化钠含量测定滴定终点突跃明显,平均加样回收率(n=9)为99.8%。甘油和果糖进样浓度分别在0.888~4.44和0.488~2.44 mg·mL~(-1)的范围内线性关系良好,检测限(S/N=3)分别为0.042和0.013 mg·mL~(-1),定量限(S/N=10)分别为0.14和0.04 mg·mL~(-1),平均加样回收率(n=9)分别为99.4%和99.5%。10批样品测定结果:氯化钠的含量相对于标示量为98.3%~99.8%,甘油为98.7%~99.6%,果糖为95.2%~96.4%;本方法测定结果与中国药典方法测定结果基本吻合,相对偏差≤1.0%。结论:与中国药典方法相比,本法采用的色谱柱适用面广、便宜易得,待测组分在示差折光检测器上的色谱响应较紫外检测器好。本法可用于甘油果糖氯化钠注射液中甘油、果糖、氯化钠3种成分的含量测定。
[Abstract]:Objective: to improve the method for the determination of glycerol, fructose and sodium chloride in glycerol fructose sodium chloride injection. Methods: the content of sodium chloride was determined by AgNO_3 titration. The content of glycerol and fructose was determined by high performance liquid chromatography-differential refraction method, the chromatographic conditions were as follows: the mobile phase was acetonitrile-water (75:25), the flow rate was 1.0 mL min~ (-1), the column temperature was 35 鈩，

本文编号：2212524