赖氨肌醇维B_(12)口服溶液中赖氨酸与维生素B_(12)含量测定

目的建立赖氨肌醇维B12口服溶液中赖氨酸与维生素B12含量测定方法。方法采用电位滴定法测口服液中盐酸赖氨酸含量;高效液相色谱法测定维生素B12的含量,色谱条件为C18柱,以乙腈-0.05mol/L磷酸二氢钠(16︰84)用磷酸调节pH=3.3为流动相,流速1mL/min,检测波长210nm。结果电位滴定法测定口服液中盐酸赖氨酸的回归方程为V=0.1055G-0.3425,r=0.9996。精密度试验的RSD%为0.44%,溶液稳定性试验的RSD%为0.59%,低中高三个浓度的平均回收率分别为99.54%、100.08%、99.71%,3批样品含量测定分别为100.72%、99.45%和99.76%;测定维生素B12的回归方程为A=0.8407C-0.0425,r=0.9998,精密度试验RSD为0.99%,溶液稳定性试验RSD为1.08%,最低检出限与定量限分别是0.12μg/mL和0.40μg/mL,低中高三个浓度平均回收率分别是98.20%、99.00%和99.07%,对3批样品的检测结果分别是100.81%、99.43%、98.25%。结论本研究测定盐酸赖氨酸和维生素B12的方法均准确可行,可用于本口服液的质量控制。

Determination of Lysine and Vitamin B12 in Lysine Inosite and Vitamin B12 Oral Solution

Objective To determine Lysine and Vitamin B12 in Lysine,Inosite and Vitamin B12 Oral Solution.Methods Potentiometric titration was used to determine Lysine and HPLC was used to determine vitamin B12.The HPLC condition:C18 was used,acetone 0.05mol/L Sodium Dihydrogen Phosphate(16︰84,pH was adjusted to 3.3 by Phosphoric acid),mobile rate 1mL/min,detection wavelength at 210nm.Results Potentiometric titration to determine lysine Regression equation was V=0.1055G-0.3425,r=0.9996.The Precision test RSD was 0.44% and solution stability RSD was 0.59%.The recovery rates of three different concentrations(low concentration,middle concentration and high concentration) were 99.54%、100.08%、99.71% respectively.The HPLC method to determine vitamin B12 Regression equation is A=0.8407C-0.0425,r=0.9998.The Precision test RSD was 0.99% and solution stability RSD was 1.08%.The recovery rates of three different concentrations(low concentration,middle concentration and high concentration)were 98.20%、99.00%、99.07% respectively.The LOD and LTD is 0.12μg/mL and 0.40μg/mL.Conclusion The assay method can be used to determine lysine and vitamin B12 and can be used to control the oral solution quality.