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HPLC波长切换法同时测定脑心通胶囊中7种指标成分

张生杰, 王丽, 田志梅

张生杰, 王丽, 田志梅. HPLC波长切换法同时测定脑心通胶囊中7种指标成分[J]. 中国药科大学学报, 2019, 50(5): 572-578. DOI: 10.11665/j.issn.1000-5048.20190510
引用本文: 张生杰, 王丽, 田志梅. HPLC波长切换法同时测定脑心通胶囊中7种指标成分[J]. 中国药科大学学报, 2019, 50(5): 572-578. DOI: 10.11665/j.issn.1000-5048.20190510
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ZHANG Shengjie, WANG Li, TIAN Zhimei. Simultaneous determination of seven index components in Naoxintong capsule by HPLC wavelength switching method[J]. Journal of China Pharmaceutical University, 2019, 50(5): 572-578. DOI: 10.11665/j.issn.1000-5048.20190510
Citation: ZHANG Shengjie, WANG Li, TIAN Zhimei. Simultaneous determination of seven index components in Naoxintong capsule by HPLC wavelength switching method[J]. Journal of China Pharmaceutical University, 2019, 50(5): 572-578. DOI: 10.11665/j.issn.1000-5048.20190510
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HPLC波长切换法同时测定脑心通胶囊中7种指标成分

  • 武威市药品检验检测中心

Simultaneous determination of seven index components in Naoxintong capsule by HPLC wavelength switching method

摘要

    摘要
  • 摘要: 建立HPLC-DAD波长切换法(240，280，316，403 nm)同时测定脑心通胶囊中羟基红花黄色素A、芍药苷、阿魏酸、丹酚酸B、山柰素、芒柄花素、丹参酮ⅡA等 7种指标成分的含量，结合数理统计评价不同批次脑心通胶囊的质量差异。采用HPLC波长切换法，Capcell PAK C18 MGⅡ色谱柱(250 mm×4.6 mm，5.0 μm)，甲醇-乙腈(25∶75，A)-0.1%甲酸水溶液(B)为流动相，梯度洗脱，流速1 mL/min，柱温30 ℃。同时测定20批次脑心通胶囊中7种指标成分，对含量测定结果进行数理统计分析。结果显示，7种指标成分羟基红花黄色素A(403 nm)在2.30~11.50 mg/L(r=0.999 2)、芍药苷(240 nm)在8.81~44.05 mg/L(r=0.999 6)、阿魏酸(316 nm)在1.22~6.10 mg/L(r=0.999 6)、丹酚酸B(280 nm)在11.61~58.05 mg/L(r=0.999 4)、山柰素(403 nm)在1.16~5.80 mg/L(r=0.999 4)、芒柄花素(240 nm)在0.12~0.60 mg/L(r=0.999 5)、丹参酮IIA(280 nm)在2.28~11.40 mg/L(r=0.999 5)线性关系良好；精密度良好，RSD 均小于2.0%；重复性良好，RSD均小于2.0%；在室温条件下24 h内稳定；平均加样回收率在97.35%~101.02%，RSD 均小于2.0%。20批样品中各指标成分含量范围如下:羟基红花黄色素A 0.213~0.369 mg/g、芍药苷1.535~3.217 mg/g、阿魏酸0.153~0.236 mg/g、丹酚酸B 2.563~3.271 mg/g、山柰素0.103~0.181 mg/g、芒柄花素0.022~0.028 mg/g、丹参酮ⅡA 0.466~0.698 mg/g。建立的HPLC-DAD法同时测定脑心通胶囊中的7种成分，方法准确、可靠、重复性好，可作为脑心通胶囊质量控制的分析方法。
    Abstract: An HPLC-DAD wavelength switching method(240 nm, 280 nm, 316 nm, 403 nm)was developed for simultaneous determination of seven index components: hydroxysafflor yellow A, paeoniflorin, ferulic acid, salvianolic acid B, kaempferol, formononetin and tanshinone IIA in Naoxintong capsule. The qualities of different batches of Naoxintong capsules were evaluated by statistical analysis. Seven index components in 20 batches of Naoxintong capsules were simultaneously determined by HPLC wavelength switching method with Capcell PAK C18 MG II column(250 mm × 4. 6 mm, 5. 0 μm). The mobile phase consisted of methanol-acetonitrile(25 ∶75, A)-0. 1% formic acid aqueous solution(B)with a gradient elution program and a flow rate of 1. 0 mL/min, and the column temperature was 30 °C. The results were analyzed by statistical analysis to evaluate the differences in the quality of Naoxintong capsules. Results showed that the seven active components were well separated and showed good linearity hydroxysafflor yellow A(403 nm)2. 30- 11. 50 mg/L(r=0. 999 2), paeoniflorin(240 nm)8. 81- 44. 05 mg/L(r=0. 999 6), ferulic acid(316 nm)1. 22- 6. 10 mg/L(r=0. 999 6), salvianolic acid B(280 nm)11. 61- 58. 05 mg/L(r=0. 999 4), kaempferol(403 nm)1. 16-5. 80 mg/L(r=0. 999 4), formononetin(240 nm)0. 12- 0. 60 mg/L(r=0. 999 5)and tanshinone IIA(280 nm)2. 28- 11. 40 mg/L(r=0. 999 5). The precision was good and RSD was less than 2. 0%, The repeatability was good and RSD was less than 2. 0%. The stability was good in 24 h. The average recoveries were between 97. 35%- 101. 02% and RSD was less than 2. 0%. The contents of target components in Naoxintong capsules, hydroxysafflor yellow A was 0. 213- 0. 369 mg/g, paeoniflorin was 1. 535- 3. 217 mg/g, ferulic acid was 0. 153- 0. 236 mg/g, salvianolic acid B was 2. 563- 3. 271 mg/g, kaempferol was 0. 103- 0. 181 mg/g, formononetin was 0. 022- 0. 028 mg/g, and tanshinone IIA was 0. 466- 0. 698 mg/g. HPLC wavelength change and gradient elution method was established for simultaneous determination of seven index components in Naoxintong capsule. The method is accurate, sensitive, reliable, and repeatable, and can be used for the quality control of Naoxintong capsule.
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  • 刊出日期:  2019-10-24

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