转化糖电解质注射液中果糖与无水葡萄糖含量测定方法的研究

Determination of fructose and anhydrous glucose in invert glucose electrolyte injection

建立转化糖电解质注射液中果糖与无水葡萄糖含量测定方法,为转化糖电解质注射液中果糖与无水葡萄糖质量标准的建立提供依据。采用高效液相色谱法(示差法)进行测定,按照分析方法验证指导原则进行方法学验证。该方法专属性、系统适用性良好。无水葡萄糖浓度在4.9231~49.2306 mg/mL范围内,浓度与主峰面积线性相关,线性方程为Y=287569 X+10201,相关系数r=0.9994,线性关系良好。果糖浓度在5.2019~52.0191mg/mL范围内,果糖的浓度与主峰面积线性相关,线性方程为Y=271009 X+8074.3,相关系数r=0.9994,线性关系良好。进样精密度试验、重复性试验RSD小于2.0%。无水葡萄糖和果糖的回收率分别为100.7%~101.7%和100.6%~101.9%,平均值分别为101.2%和101.3%,RSD分别为0.32%和0.41%,小于2.0%,准确度良好。无水葡萄糖和果糖的定量限分别为98.46ng和104.0ng,相当于标示量的0.04%,均能准确测定,本方法灵敏度较好。本方法溶液稳定性、耐用性等均符合相关规定,可用于转化糖电解质注射液中果糖与无水葡萄糖含量测定。

Objective:A method for the determination of fructose and anhydrous glucose in invert sugar electrolyte injection was established to provide a basis for the establishment of quality standards for fructose and anhydrous glucose in invert sugar electrolyte injection.Methods:HPLC(differential method)was used for determination,and the methodology was verified according to the guiding principles of analytical method verification.The method is specific and has good system applicability.Results:The concentration of anhydrous glucose is in the range of 4.9231~49.2306 mg/mL,the concentration is linearly related to the main peak area,the linear equation is Y=287569 X+10201,the correlation coefficient r=0.9994,the linear relationship is good.The RSD of injection precision test and repeatability test is less than 2.0%.The recovery rates of anhydrous glucose and fructose were 100.7%~101.7%and 100.6%~101.9%,respectively,with an average value of 101.2%and 101.3%,respectively.The RSD was 0.32%and 0.41%,which was less than 2.0%,and the accuracy was good.The limits of quantification of anhydrous glucose and fructose are 98.46ng and 104.0ng,respectively,which are equivalent to 0.04%of the labeled amount.Both can be accurately determined.The sensitivity of this method is good.Conclusion:The solution stability and durability of this method are in compliance with relevant regulations,and can be used to determine the content of fructose and anhydrous glucose in inverted sugar electrolyte injection.