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机构地区:[1]第二军医大学长征医院药学部,上海200003
出 处:《药学实践杂志》2008年第5期354-356,共3页Journal of Pharmaceutical Practice
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.
分 类 号:R917[医药卫生—药物分析学]
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