HPLC法测定小儿复方赖氨酸颗粒中盐酸赖氨酸的含量

Determination of Lysine Hydrochloride in Pediatric Compound Lysine Granules by HPLC

目的建立小儿复方赖氨酸颗粒中盐酸赖氨酸的HPLC检测方法。方法色谱柱为Welch Utimate XB-NH2(250mm×4.6mm,5μm),流动相为0.05mol·L-1磷酸二氢钾溶液-乙腈(40∶60),流速为1.0m L·min-1,柱温为30℃,进样量为5μL,检测波长为200nm。结果在0.12746 mg·m L-1~2.5492 mg·m L-1范围内与峰面积呈良好的线性关系,r=0.9999,平均回收率为97.64%,RSD为1.06%(n=9)。结论该方法简便,准确,重复性好,可用于小儿复方赖氨酸颗粒的质量控制。

OBJECTIVE To establish an HPLC method for determination of lysine hydrochloride in Pediatric Compound Lysine Granules. METHODS The content determination was performed on a Welch Utimate XB-NH2 （ 250mm × 4. 6mm, 5μm） column with 0. 05 mol · L - 1 potassium dihydrogen phosphate solution-acetonitrile （ 40： 60 ） as the mobile phase. The flow rate was 1.0mL· min-1. The column temperatuie was 30μ. All the injection volumn was 5μL and the detection wavelength was 200nm. RESULTS The linear range of lysine hydrochloride was within 0. 12746 - 2. 5492μg·mL-1, r = 0. 9999, the average sample recovery was 97.64% with RSD of 1.06% （ n = 9 ）. CONCLUSION This method is simple, accurate and reproducible, and it can be used for the quality control of Pediatric Compound Lysine Granules.