HPLC检测长春西汀葡萄糖注射液中降解产物5-羟甲基糠醛

Determination of degradation product 5-HMF in Vinpocetine and Glucose injection by HPLC

目的建立测定长春西汀葡萄糖注射液中降解产物5-羟甲基糠醛(5-HMF)含量的方法.方法采用HPLC法,色谱柱为Kromasil ODS-1 C18(4.6 mm×250 mm);流动相为0.2%磷酸-甲醇(75∶25);流速1 ml·min-1;检测波长284 nm.以外标法测定5-HMF的含量.结果在1.0～20.0 μg·ml-1范围内,对照品峰面积与浓度的线性关系良好(r=0.9999),加样平均回收率为99.5%,RSD＝1.0%(n=5),最低检测浓度为7.7 ng·ml-1.结论所用方法简便、准确、重复性好,可用于长春西汀葡萄糖注射液中降解产物5-HMF的检测.

OBJECTIVE To establish a method for determination of the degradation product 5 - HMF in Vinpocetine and Glucose injection. METHODS An HPLC method was adopted with Kromasil ODS- 1 Gs column（4.6 mm × 250 mm）.0.2% phosphoric acid - methanol （75 ： 25） as mobile phase was used, with flow rate of 1.0 nd·min^- 1, and the detective wavelength was set at 284 nm. The external standard method was adopted for the assay of 5 - HMF. RESULTS The calibration curve of 5 - HMF was linear within the range of 1.0 - 20.0 μg·ml^- 1 （ r = 0,9999）. The average recovery of 5 - HMF was 99.5 % with RSD of 1.0 % （ n = 5）. The concentration of detection limit was 7,7 ng·ml^-1. CONCLUSION The method is simple, reliable, accurate and it can be applied to determination of degradation product 5 - HMF in Vinpocetine and Glucose injection.