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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 HPLC method for the simultaneous determination of L-glutamine and ghrelin sodium in L-glutamine sodium gorinate particles. Methods: Kromasil100-5C18 column (4.6mm × 250mm, 5μm) was used as the mobile phase with acetonitrile-0.05% sodium decanesulfonate solution (adjusted to pH 2.6 with phosphoric acid) (25:75). The detection wavelength was 210nm. Results: The linear range of L-glutamine was 248.2 ~ 2233.8μg · mL-1, and the linear range of gaba was 0.892 ~ 8.028μg.mL-1. The repeatability test RSD was 0.9% and 1.8% The recoveries were 100.4% and 99.6% respectively. Conclusion: The method of simultaneous determination of two components in the L-glutamine ghrelin sodium particle content, fast, simple and accurate, can be used for the quality control of the preparation.