反相高效液相色谱法同时测定L-谷氨酰胺呱仑酸钠颗粒中L-谷氨酰胺和呱仑酸钠的含量

RP-HPLC simultaneous determination of L-glutamine and sodium gualenate in L-glutamine and sodium gualenate granules

目的:建立同时测定L-谷氨酰胺呱仑酸钠颗粒中L-谷氨酰胺和呱仑酸钠含量的HPLC方法。方法:采用Kromasil100-5C18色谱柱(4.6mm×250mm,5μm),以乙腈-0.05%癸烷磺酸钠溶液(用磷酸调pH至2.6)(25∶75)为流动相,检测波长为210nm。结果:L-谷氨酰胺的线性范围为248.2～2233.8μg·mL-1,呱仑酸钠的线性范围为0.892～8.028μg.mL-1,重复性试验RSD分别为0.9%和1.8%,平均回收率分别为100.4%和99.6%。结论:本方法同时测定L-谷氨酰胺呱仑酸钠颗粒中2种组分的含量,快速、简便、准确,可用于该制剂的质量控制。

Objective：To establish an RP-HPLC method for simultaneous determination of L-glutamine and sodium gualenate in L-glutamine and sodium gualenate granules.Methods：The analysis was carried out on a Kromasil 100-5 C18 column（4.6 mm×250 mm,5 μm） with mobile phase of acetonitril-0.05% sodium decane-1-sulfonate solution （adjusted to pH=2.6 with phosphoric acid） （25：75）,the detection wavelength was set at 210 nm.Results：The calibration curves were linear within the range of 248.2-2233.8 μg·mL-1 for L-glutamine and 0.892-8.028 μg·mL-1for sodium gualenate.The average recoveries were 100.4% and 99.6%,respectively.Conclusion：The method can be easily employed with high precision and accuracy for simultaneous determination of the two components in L-glutamine and sodium gualenate granules,and can be used for its quality control.