Development and optimization of SPE-HPLC-UV/ELSD for simultaneous determination of nine bioactive components in Shenqi Fuzheng Injection based on Quality by Design principles

Analytical and Bioanalytical Chemistry
Lu Wang, Haibin Qu

Abstract

A method combining solid phase extraction, high performance liquid chromatography, and ultraviolet/evaporative light scattering detection (SPE-HPLC-UV/ELSD) was developed according to Quality by Design (QbD) principles and used to assay nine bioactive compounds within a botanical drug, Shenqi Fuzheng Injection. Risk assessment and a Plackett-Burman design were utilized to evaluate the impact of 11 factors on the resolutions and signal-to-noise of chromatographic peaks. Multiple regression and Pareto ranking analysis indicated that the sorbent mass, sample volume, flow rate, column temperature, evaporator temperature, and gas flow rate were statistically significant (p < 0.05) in this procedure. Furthermore, a Box-Behnken design combined with response surface analysis was employed to study the relationships between the quality of SPE-HPLC-UV/ELSD analysis and four significant factors, i.e., flow rate, column temperature, evaporator temperature, and gas flow rate. An analytical design space of SPE-HPLC-UV/ELSD was then constructed by calculated Monte Carlo probability. In the presented approach, the operating parameters of sample preparation, chromatographic separation, and compound detection were investigated simultaneously. Eig...Continue Reading

References

Oct 31, 2006·Journal of Separation Science·Jian-Bo WanKarl Wah-Keung Tsim
Feb 1, 2011·Journal of Pharmaceutical Sciences·Frederick G Vogt, Alireza S Kord
Sep 4, 2012·Analytical and Bioanalytical Chemistry·Serena OrlandiniSandra Furlanetto
Dec 19, 2013·Journal of the American Society for Mass Spectrometry·Lu WangHaibin Qu
Feb 11, 2014·Journal of Chromatography. a·Eftichia Karageorgou, Victoria Samanidou
Oct 31, 2014·Journal of Biopharmaceutical Statistics·Eric RozetBruno Boulanger

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Citations

Feb 13, 2018·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Hua YinBinjun Yan
May 26, 2017·Evidence-based Complementary and Alternative Medicine : ECAM·Bashir Mohammed AbubakarAlina Wagiran

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