HPLC法测定肾复康Ⅱ号胶囊中5个成分的含量  

Content determination of five constituents in ShenfukangⅡcapsule by HPLC

作　　者：尹继瑶 沈霞 胡静 崔小敏[2] 任慧[2] 曲彤 李宁 屈凯 陈志永 YIN Jiyao;SHEN Xia;HU Jing;CUI Xiaomin;REN Hui;QU Tong;LI Ning;QU Kai;CHEN Zhiyong(College of Basic Medicine,Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712083,China;Shaanxi Academy of Traditional Chinese Medicine,Xi’an 710003,China;Dept.Two of Nephropathy,Shaanxi Provincial Chinese Medicine Hospital,Xi’an 710003,China)

机构地区：[1]陕西中医药大学基础医学院,陕西咸阳712083 [2]陕西省中医药研究院,西安710003 [3]陕西省中医医院肾病二科,西安710003

出　　处：《中国药房》2022年第15期1838-1841,共4页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81603454);国家中医药管理局中医药科学技术研究专项课题(No.GZY-KJS-2021-005);全国中医临床特色技术传承骨干人才培训项目;陕西省中医药优秀中青年科技骨干人才队伍建设项目;陕西中医药大学校级科研课题研究生创新项目(No.2021CX17)。

摘　　要：目的建立同时测定肾复康Ⅱ号胶囊中莫诺苷、马钱苷、芍药苷、丹酚酸B和淫羊藿苷含量的高效液相色谱(HPLC)法。方法采用Agilent 5 TC-C18色谱柱,流动相为乙腈-0.1%磷酸溶液(梯度洗脱),柱温为30℃,流速为1 mL/min,检测波长为240 nm,进样量为10μL。结果莫诺苷、马钱苷、芍药苷、丹酚酸B和淫羊藿苷的检测质量浓度分别在4.80~240.00、4.84~242.00、7.00~350.00、4.72~236.00、5.18~259.00μg/mL范围内与各自峰面积呈良好的线性关系(r≥0.9998);精密度、稳定性、重复性试验的RSD均小于3%(n=6);平均加样回收率为97.22%~101.36%,RSD为1.19%~2.43%(n=6)。5批样品中上述5个成分的含量范围依次为2.0193~2.3600、1.6242~1.8471、5.6377~6.8280、5.0159~5.7170、1.2088~1.7546 mg/g。结论该方法简便、准确,重复性好,可用于提升肾复康Ⅱ号胶囊的质量控制水平。OBJECTIVE To develop an HPLC method for the simultaneous determination of morroniside,loganin,paeoniflorin,salvianolic acid B and icariin in ShenfukangⅡcapsule.METHODS The determination was performed on Agilent 5 TC-C18 column with mobile phase consisted of acetonitrile-0.1%phosphate acid(gradient elution)at the flow rate of 1 mL/min.The column temperature was 30℃,and detection wavelength was set at 240 nm.The sample size was 10μL.RESULTS The linear range of morroniside,loganin,paeoniflorin,salvianolic acid B and icariin were 4.80-240.00,4.84-242.00,7.00-350.00,4.72-236.00 and 5.18-259.00μg/mL(r≥0.9998),respectively.RSDs of precision,stability and reproducibility tests were all lower than 3%(n=6).Average recoveries were 97.22%-101.36%with the RSDs of 1.19%-2.43%(n=6).The contents of above 5 components in 5 batches of samples were 2.0193-2.3600,1.6242-1.8471,5.6377-6.8280,5.0159-5.7170 and 1.2088-1.7546 mg/g,respectively.CONCLUSIONS The method is simple,accurate and reproducible.It can improve the quality control level of ShenfukangⅡcapsule.

关 键 词：肾复康Ⅱ号胶囊 含量测定 高效液相色谱法 莫诺苷 马钱苷 芍药苷 丹酚酸B 淫羊藿苷 

分 类 号：R917[医药卫生—药物分析学]