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。
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
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
Keywords
Baoerning granulesmulti-components with a single markerrelative correction factorHPLC