HPLC法测定肾复康Ⅱ号胶囊中5个成分的含量
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篇名: HPLC法测定肾复康Ⅱ号胶囊中5个成分的含量
TITLE: Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC
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Agilent5TC-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1mL/min,检测波长为240nm,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、1.2088~1.7546mg/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。
ABSTRACT: OBJECTIVE To develop an HPLC method for the simultaneous dete rmination of morroniside ,loganin,paeoniflorin, salvianolic acid B and icariin in Shenfukang Ⅱ capsule. 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 10 μL. 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 5.18-259.00 μg/mL(r≥0.999 8),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 2.019 3-2.360 0,1.624 2-1.847 1,5.637 7-6.828 0,5.015 9-5.717 0 and 1.208 8-1.754 6 mg/g,respectively. CONCLUSIONS The method is simple ,accurate and reproducible. It can improve the quality control level of Shenfukang Ⅱ capsule.
期刊: 2022年第33卷第15期
作者: 尹继瑶,沈霞,胡静,崔小敏,任慧,曲彤,李宁,屈凯,陈志永
AUTHORS: YIN Jiyao,SHEN Xia,HU Jing,CUI Xiaomin ,REN Hui,QU Tong,LI Ning,QU Kai,CHEN Zhiyong
关键字: 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
KEYWORDS: Shenfukang Ⅱ capsule;content determination ;HPLC method ;morroniside;loganin;paeoniflorin;salvianolic
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