HPLC-ELSD测定炎琥宁中钠钾摩尔质量比

Determination of Molar Mass Ratio of Sodium to Potassium in Yan Huning by HPLC-ELSD

关键词:  炎琥宁  钠钾摩尔质量比  高效液相色谱法-蒸发光散射检测

Key words:  Yan Huning  molar mass ratio of sodium to potassium  HPLC-ELSD

摘要:

目的 建立一种通用的炎琥宁原料中钠钾摩尔质量比测定方法。方法 采用SIELC Primesep A型色谱柱（4.6 mm×250 mm，5 μm），以水-乙腈-三氟乙酸（400：600：2）为流动相；流速为1 mL·min^-1；柱温为30℃；蒸发光散射检测器（漂移管温度105℃，载气流速3.2 L·min^-1）。结果 炎琥宁与钠、钾峰分离良好，钠与钾分别在6.841 9~34.209 6 μg·mL^-1与10.749 8~53.748 7 μg·mL^-1内，相应的峰面积的对数与浓度的对数呈良好的线性关系；平均回收率分别为100.1%（RSD=1.9%），98.5%（RSD=1.0%）。结论 该法简便、快速、经济，可准确的检测出炎琥宁原料药中钠、钾摩尔质量比，为其质量控制提供了可靠的检测依据。

Abstract:

OBJECTIVE To establish a general detection method for determination of the molar mass ratio of sodium to potassium in Yan Huning material. METHODS The determination method was developed on a SIELC Primesep A column(4.6 mm×250 mm, 5 μm), with water-acetonitrile-trifluoroacetic acid (400:600:2) as mobile phase at a flow rate of 1.0 mL·min^-1. The column temperature was maintained at 30℃ and detection was ELSD (drift tube temperature was 105℃ and carrier gas flow rate was 3.2 L·min^-1). RESULTS Excellent resolution was shown between the peaks of Yan Huning and sodium and potassium. Good linearity were demonstrated for sodium and potassium in the concentration range of 6.841 9-34.209 6 μg·mL^-1 and 10.749 8-53.748 7 μg·mL^-1 respectively. The average recovery rates were 100.1% (RSD=1.9%) and 98.5%(RSD=1.0%), respectively. CONCLUSION The method was simple, fast and economy, and can be applied in the detection for the molar mass ratio of sodium to potassium in Yan Huning material and provide reliable detection basis for its quality control.