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 C_(18)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。
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, 5 μm ） , using MeOH ： 0.05 mol/L KHEPO4 （ 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.
出处
《药学实践杂志》
CAS
2008年第5期354-356,共3页
Journal of Pharmaceutical Practice
