示差折光-HPLC法测定复方氨基酸注射液(18AA)中山梨醇的含量

Determination of sorbitol in compound amino acid injection( 18AA) by HPLC with refractive index detector

目的建立示差折光-HPLC测定复方氨基酸注射液(18AA)中山梨醇含量的方法。方法采用Rezex RCMMonosaccharide Ca2+色谱柱(300 mm×7.80 mm),以水为流动相,流速为0.5 ml/min,柱温为80℃,在示差折光检测器上检测,温度为55℃。结果山梨醇浓度在968.8μg/ml^8719μg/ml范围内与峰面积呈良好的线性关系(r=1.000);平均加样回收率为100.1%(RSD=0.50%,n=9);样品溶液在24 h内基本稳定;最低定量限为9.688μg/ml。结论该方法操作简单,结果准确,重现性好,可用于测定复方氨基酸注射液(18AA)中山梨醇的含量。

Objective To establish a method to determine the content of sorbitol in compound amino acid injection（18AA） by HPLC with refractive index detector. Methods Rezex RCM - Monosaccharide Ca ＋ 2 column（300 mm × 7.80 mm） was adopt- ed with water as mobile phase at a flow rate of O. 5 ml/min. The column temperature was 80 ~C and the detector temperature was 55 ℃. Results The concentration - response relationship was linear in the range of 968.8 μg/ml - 8719 μg/ml （ r = 1. 000）. The average recovery was 100.1% （RSD =0.50%, n =9）. The sample solution was stable within 24 hours and the lowest limit of quantitation was 9. 688 μg/ml. Conclusion The method provides a： selective , simple and accurate feasible way for the de- termination of the content of sorbitol in compound amino acid injection（18AA）.