离子排斥柱分离 /蒸发光散射检测同时测定天冬氨酸钾镁-山梨醇注射液中的天冬氨酸和山梨醇

Simultaneous Analysis of Aspartic Acid and Sorbitol in Potassium Magnesium Aspartate and Sorbitol Injection by Ion-Exclusion Chromatography with Evaporative Light-Scattering Detection

采用TSKgelOApak A离子排斥柱分离、蒸发光散射检测同时测定了天冬氨酸钾镁 山梨醇注射液中的天冬氨酸和山梨醇。在流动相为水 (含 0 1% (体积分数 )三氟乙酸 ) 甲醇 (体积比为 9∶1)溶液、柱温为室温的条件下 ,天冬氨酸和山梨醇的质量浓度为 2 0 0mg/L～ 2 0 0 0mg/L时与其峰面积具有良好的线性关系 (r =0 999)。该方法对天冬氨酸和山梨醇的检测下限分别为 30mg/L和 2 0mg/L。测定结果表明 ,该注射液的光、热稳定性非常好。

An ion exclusion chromatographic (IEC) method with evaporative light scattering detector (ELSD) was established for the simultaneous analysis of the aspartic acid and sorbitol in Potassium Magnesium Aspartate and Sorbitol Injection. This procedure eliminates the need for complex derivatization schemes since ELSD can detect aspartic acid and sorbitol directly. An ion exclusion column (TSKgel OApak A column, 7 8 mm i d ×300 mm, 5 μm, Tosho, Japan) was used for separation. The mobile phase was a mixture of aqueous solution (containing 0 1% (volume fraction) trifluoroacetic acid) methanol (9∶1, volume ratio). Under the above conditions aspartic acid and sorbitol were separated to baseline in 12 min. Regression equations revealed linear relationship (correlation coefficient: 0 999) between the concentrations of the analytes injected and the peak areas of the analytes detected by ELSD. The detection limits of ELSD ( S/N =3) were about 30 mg/L and 20 mg/L for aspartic acid and sorbitol, respectively.