门冬氨酸鸟氨酸原料药中的马来酸含量测定方法的改进

Improvement of Determination Method of Maleic Acid in Ornithine Aspartate

目的:改进高效液相色谱法的色谱条件,准确、稳定地测定门冬氨酸鸟氨酸原料药中的马来酸含量。方法:采用高效液相色谱法,色谱柱:BIO-RAD Aminex-HPX-87H Ion Exclusion Column,流动相:0.004 mol/L硫酸溶液,检测波长:214 nm,柱温:30℃,流速:0.6 mL/min,进样量:10 uL。结果:马来酸浓度在0.25922~4.14752 ug/mL范围内呈现良好的线性关系(R=0.9999);定量限为2.59 ng,检出限为0.78 ng;加样回收率的范围在97.85%~99.06%之间,相对标准偏差(RSD)为0.44%(n=9)。结论:此方法测定门冬氨酸鸟氨酸原料药中的马来酸,简便、准确、专属性强。

Objective: To improve the chromatographic conditions of High-performance liquid chromatography acid for the accurate and stable determination of maleic acid in ornithine aspartate raw materials. Methods: A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY COLUMN, BIO-RAD Aminex-hpx-87 h Ion Exclusion Column, mobile phase: 0.004 mol/L sulfuric acid solution, detection wavelength: 214 nm, Column temperature: 30 ℃, flow rate: 0.6 mL/min,injection volume: 10 uL. Results: MALEIC ACID showed a good linear relationship in the range of 0.25922~4.14752 ug/mL(r=0.9999), the limit of quantitation was 2.59 ng, the limit of detection was 0.78 ng, the recoveries were 97.85 %~99.06 %, the relative standard deviation(RSD) was 0.44 %(N=9). Conclusion: This method is simple, accurate and specific for the determination of maleic acid in ornithine aspartate.