摘要:
目的: 建立封管用枸橼酸钠注射液中枸橼酸盐的含量测定方法。 方法: 采用HPLC法,选用Diamonsil C18色谱柱,以甲醇-0.05 mol/L磷酸二氢钾(pH调至2.5~2.8)(5:95,v:v)为流动相,流速为1.0 mL/ min,紫外检测波长210 nm。 结果: 枸橼酸盐在0.5~6 mg/mL范围内呈良好的线性关系(r=0.999 9,n= 5);平均加样回收率为98.79%(RSD=1.08%);3批封管用枸橼酸钠注射液中的枸橼酸盐标示含量分别为100.51%、98.22%、97.78%。 结论: 本方法操作简便、快速、结果准确、可靠,适用于该制剂中枸橼酸盐的含量测定。
Abstract:
Objective:To establish a content determination method of citrate in sodium citrate injection for catheter locking. Methods:HPLC was used to determine citrate on Diamonsil C18 column(250 mm×4.6 mm,5μm),using MeOH:0.05 mol/L KH2PO4(adjusted to pH 2.5~2.8 by H3PO4)(5:95,v:v)as a mobile phase with a flow rate at 1.0 mL/min and UV wavelengh of 210 nm.Results:The calibration curve of citrate was line in the range of 0.5~6 mg/mL(r=0.999 9,n=5).The average recovery was 98.79% (RSD=1.08%).The relative contents of citrate in three batch of citrate in sodium citrate injection for catheter locking were 100.51%,98.22% and 97.78%,respectively.Conclusion:This method was simple,rapid,accurate and suitable for the quality control of citrate.