蒸发光散射法测定谷丙甘氨酸胶囊的含量

Content Determination of Glutamic Acid,Alanine Acid and Glycine Acid Capsules by HPLC-ELSD

目的:采用HPLC-ELSD法建立了测定谷丙甘氨酸胶囊中3种氨基酸含量的方法。方法:采用Capcell Pak C18(4.6 mm×250 mm,5μm)色谱柱,流动相为0.4%三氟乙酸,流速1.0 mL.min-1,柱温35℃。蒸发光散射检测器条件为撞击器关闭状态,漂移管温度105℃,载气流速2.5 L.min-1。结果:谷氨酸、丙氨酸、甘氨酸的线性范围依次为:0.53～2.65,0.20～1.00,4～20 g.L-1,相关系数依次为:0.998 9,0.998 4,0.999 1。回收率(n=9)依次为:99.4%,100.3%,99.8%(RSD分别为1.9%,1.5%,0.9%)。结论:该方法操作简便,灵敏度高,快速、准确,适用于谷丙甘氨酸胶囊含量的质量控制。

Objective：To establish an HPLC-EKSD method for determination of the content of Glutamic Acid, Alanine Acid and Glycine Acid Capsules. Methods：The chromatorgraphic condition was following： Capcell Pak C18 （4. 6 mm×250mm,5μm） , the mobile phase was composed of 0. 4% trifluoroaeetic acld,flow rate was at 1.0 mL · min^-1 ,column temprature was 35 ℃ The conditions of ELSD were following： impactor was off, drift tube was at 105℃ , flow rate was at 2. 5 L ·min^-1. Results：The calibration curves showed good linearity in the range of 0. 53 - 2. 65 g · L ^- 1 （ Glutamic Acid ）, 0. 20 - 1.00 g · L ^- 1 （ Alanine Acid ）, 4 - 20 g · L ^- 1 （ Glyeine Acid）, correlation coefficients were 0. 998 9,0. 998 4,0. 999 1. The average recoveries （n = 9 ） were 99.4% , 100. 3% ,99. 8% ;and RSD were 1.9% , 1.5% ,0.9%. Conclusion：Tbe method is good in the aspect of reproducibility and sensitivity, it can be applied to the quality control of Glutamic Acid,Alanine Acid and Glycine Acid Capsules.