Study on the quality consistency of Xiao'er Kechuanling oral liquid evaluated by HPLC-QAMS

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.