关键词: font-size:medium, ">葡萄糖；含量测定；高效液相色谱；电喷雾检测器；口服五维赖氨酸葡萄糖

Abstract: Objective： To establish a high-performance liquid chromatography-charged aerosol detector (HPLC-CAD) method for determining the glucose content in oral five-vitamin and lysine glucose preparations， and to compare the results obtained by this method with those of the iodometric method recorded in the current quality standards. Methods： HPLC-CAD is used； the chromatographic column is Waters XBridge BEH Amide (4.6 mm×250 mm， 5 μm). The mobile phase is 0.2% triethylamine aqueous solution and acetonitrile(25∶75)； the flow rate is 1.0 mL·min-1. Clumn temperature is set at 30 ℃； the injection volume is 20 μL. Results： In the system suitability solution， baseline separation was achieved between glucose and sucrose， fructose， and lactose. The linear relationship of glucose is good within the range of 0.490 8 to 0.981 6 mg·mL-1 (r=0.999 6). The quantification limit of the method is 0.2 μg， and the recovery rate is 100.82% to 102.58% (RSD=0.8%， n=6). The glucose content in 96 batches of samples from 4 production enterprises across the country was determined using HPLC-CAD and iodometry， and the results were analyzed and compared. Due to the interference of excipients in the 4 enterprises on the iodometry method， the true content of glucose could not be reflected. The HPLC-CAD method resulted in a lower glucose content than the iodometry method， indicating a more accurate result. Conclusion： This method is simple to operate， exhibits good specificity and high sensitivity， and can accurately determine the glucose content in oral five-vitamin and lysine glucose preparations.

Key words: font-size:medium, ">Glucose； Assay； High performance liquid chromatography； Charged aerosol detector（CAD）； Oral five-vitamin and lysine glucose preparations