| 摘要: |
| 目的:建立一测多评法同时测定保儿宁颗粒中4 种成分的含量。方法:采用Zorbax Eclipse XDB C18 柱(250 mm×4. 6 mm,
5 μm),以乙腈-0. 2%磷酸溶液为流动相,梯度洗脱(0 min→14 min→15 min,乙腈15%→25%→15%),流速1. 0 mL/ min,柱温
32 ℃,检测波长215 nm。以升麻素苷为内标,分别建立毛蕊异黄酮葡萄糖苷、升麻素和5-O-甲基维斯阿米醇苷的相对校正因
子,测定各成分的含量,实现一测多评。同时采用外标法测定保儿宁颗粒中4 种成分的量,比较两种方法测得值的差异,以验证
一测多评法在测定中的准确性及可行性。结果:各相对校正因子重现性良好,外标法4 种成分在考察的浓度范围内线性关系良
好(r≥0. 999 4),加样回收率为99. 21%~100. 95%(n =6),采用校正因子计算的含量与实测含量之间比较差异无统计学意义。
结论:该方法准确可靠,可作为保儿宁颗粒多指标成分测定的质量控制方法。 |
| 关键词: 保儿宁颗粒 一测多评 相对校正因子 高效液相色谱法 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2023.01.008 |
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| 基金项目: |
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| Simultaneous Determination of Four Constituents in Baoerning Granules by QAMS |
| Huang Wei |
| (Xuzhou Food and Drug Administration and Inspection Center of Jiangsu Province, Jiangsu Xuzhou 221000, China) |
| Abstract: |
| Objective: To establish a quantitative analysis of multi-components by single-marker (QAMS) method for the simultaneous
content determination of four constituents in Baoerning granules. Methods: Zorbax Eclipse-C18 (250 mm×4. 6 mm, 5 μm)was used as
stationary phase, acetonitrile-0. 2% phosphoric acid solution with gradient elution (0 min→14 min→15 min, acetonitrile 15%→25%→
15%) at a flow rate of 1. 0 mL/ min, the column temperature at 32 ℃, and the wavelength of detection at 215 nm. Prim-Oglucosylcimifugin
was chosen as the single maker to determine the contents of pistil isoflavone glucoside, cimifugin and 5-Omethylvisammioside
in Baoerning granules. At the same time, the external standard method was used to determine the contents of four
compinents in Baoerning granules, and the differences between the two methods were compared to verify the accuracy and feasibility of
the QAMS method. Results: The relative correction factors have good reproducibility. There was a good linear relationship (r≥0. 999,4)
in the concentration range of the four compounds in the external standard method. The recoveries were 99. 21% to 100. 95% (n = 6).
There was no significant difference between the content value calculated by the correction factor and the measured value. Conclusion:
This method is accurate and reliable, and can be used for the quality control of Baoerning granules |
| Key words: Baoerning granules multi-components with a single marker relative correction factor HPLC |
