【摘要】：目的:對甘油果糖氯化鈉注射液中甘油、果糖、氯化鈉3種成分的含量測定方法進(jìn)行改進(jìn)。方法:采用AgNO_3滴定法測定氯化鈉的含量。采用高效液相色譜-示差折光法測定甘油和果糖的含量;色譜條件:使用5u氨基柱(250 mm×4.6 mm,5μm),以乙腈-水(75∶25)為流動相,流速1.0 mL·min~(-1),柱溫35℃,流通池溫度35℃。結(jié)果:氯化鈉含量測定滴定終點突躍明顯,平均加樣回收率(n=9)為99.8%。甘油和果糖進(jìn)樣濃度分別在0.888~4.44和0.488~2.44 mg·mL~(-1)的范圍內(nèi)線性關(guān)系良好,檢測限(S/N=3)分別為0.042和0.013 mg·mL~(-1),定量限(S/N=10)分別為0.14和0.04 mg·mL~(-1),平均加樣回收率(n=9)分別為99.4%和99.5%。10批樣品測定結(jié)果:氯化鈉的含量相對于標(biāo)示量為98.3%~99.8%,甘油為98.7%~99.6%,果糖為95.2%~96.4%;本方法測定結(jié)果與中國藥典方法測定結(jié)果基本吻合,相對偏差≤1.0%。結(jié)論:與中國藥典方法相比,本法采用的色譜柱適用面廣、便宜易得,待測組分在示差折光檢測器上的色譜響應(yīng)較紫外檢測器好。本法可用于甘油果糖氯化鈉注射液中甘油、果糖、氯化鈉3種成分的含量測定。
[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，

本文編號：2212524