HPLC-QAMS法评价小儿咳喘灵口服液质量一致性研究
Study on the quality consistency of Xiao'er Kechuanling oral liquid evaluated by HPLC-QAMS
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摘要: 建立高效液相色谱-一测多评法(high performance liquid chromatography-quantitative analysis of multi-components by single marker, HPLC-QAMS) 测定小儿咳喘灵口服液中15种成分的含量, 为小儿咳喘灵口服液的质量控制提供了方法依据。以水溶解样品, 色谱柱为Kromasil C18 (250 mm × 4.6 mm, 5 μm), 以乙腈-0.1%甲酸为流动相进行梯度洗脱, 柱温为30 ℃, 流速为1.0 mL·min-1, 进样量为5 μL, 检测波长254 nm; 以绿原酸为内标, 计算其他14个成分的相对校正因子, 测定含量; 并对22批样品进行聚类分析与主成分分析。15种成分在各自浓度范围内线性关系良好(r ≥ 0. 999 5), 平均加样回收率96.52%~99.02%, RSD为0.57%~1.40%; 一测多评法法所得结果与外标法接近。22批样品聚类分析分成四类; 主成分分析提取了4个主成分, 贡献率达到81.706%。结果表明, 该方法准确、专属性强, 可用于该制剂的含量测定及质量评价。Abstract: A HPLC-QAMS method was established for the simultaneous determination of 15 components in Xiao'er Kechuanling oral liquid, providing a method for its quality control. The analysis was performed on a 30 ℃ Kromasil C18 column (250 mm × 4.6 mm, 5 μm), with the mobile phase comprising of acetonitrile-0.1% formic acid flowing at 1.0 mL·min-1 in a gradient elution manner. The injection volume was 5 μL and the detection wavelength was set at 254 nm. Chlorogenic acid was used as an internal standard to calculate the relative correction factors of the other fourteen components, after which the content determination was made. Cluster analysis and principal component analysis were conducted on 22 batches of samples. Fifteen components showed good linear relationships within their own ranges (r ≥ 0.999 5), whose average recoveries were 96.52%-99.02% with the RSDs of 0.57%-1.40%. The result obtained by HPLC-QAMS approximated those obtained by external standard method. Cluster analysis of 22 batches of samples was divided into four classes. Four principal components were extracted by principal component analysis, and the contribution rate reached 81.706%. This accurate and specific method can be used for the quality control of Xiao'er Kechuanling oral liquid.
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