Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC

YIN Jiyao; SHEN Xia; HU Jing; CUI Xiaomin; REN Hui; QU Tong; LI Ning; QU Kai; CHEN Zhiyong

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Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC

更新时间：2022-11-09

- Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC
- China Pharmacy Vol. 33, Issue 15, (2022)
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YIN Jiyao, SHEN Xia, HU Jing, et al. Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC. [J]. China Pharmacy 33(15).(2022)
DOI：

YIN Jiyao, SHEN Xia, HU Jing, et al. Content determination of five constituents in Shenfukang Ⅱ capsule by HPLC. [J]. China Pharmacy 33(15).(2022) DOI：

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.

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

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Related Institution

College of Pharmacy， Shandong University of Traditional Chinese Medicine

Binzhou Key Laboratory of Chemical Drug Research and Quality Control

Binzhou Testing Center

College of Pharmacy， Hubei University of Chinese Medicine

Dept. of Pharmacy， Hubei Provincial Hospital of Traditional Chinese Medicine/the Affiliated Hospital of Hubei University of Chinese Medicine/Hubei Province Academy of Traditional Chinese Medicine

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