A versatile "Monomethod-Multiuse" strategy based on HPLC-CAD for quality control of Shengmai Formula from raw materials to preparations

Background Shengmai Formula (SMF), an important prescription for treating Qi-Yin deficiency, was composed of Ginseng Radix et Rhizoma (GR), Ophiopogon Radix (OR), and Schisandra chinensis Fructus (SC). It had developed various dosage forms, including Shengmai Yin (SMY), Shengmai Capsule (SMC), and Shengmai Injection (SMI). The quality control of SMF was detecting schisandrol A or ginsenosides Rg1 and Re in 254 or 203 nm, which ignored the control of OR. Moreover, components in GR and OR had lower ultraviolet absorption compared with SC, making it difficult to ensure their quality. Since the complexity of raw materials and preparations, establishing a rational and unified method for SMF was challenging. Charged aerosol detector (CAD) overcame the above shortcomings and can be used in the quality control of SMF. Purpose We aimed to establish a versatile analysis strategy using HPLC-CAD that can simultaneously evaluate and control the quality of raw materials and different Shengmai preparations to ensure the effectiveness of clinical application. Method By optimizing the column, column temperature, flow rate, and CAD parameters, a “Monomethod-Multiuse” strategy, which integrated multi-components characterization, authenticity identification, transfer information of raw materials and quantitative determination of Shengmai preparations, was established. Results The “Monomethod-Multiuse” strategy can simultaneously characterize 50 components from SMF (28 in GR, 13 in SC, and 9 in OR) and distinguish the raw materials with different origins and qualities, including GR and Ginseng Radix et Rhizoma Rubra (GRR), SC and Schisandrae sphenantherae Fructus (SS), OR from Sichuan (ORS), and Zhejiang (ORZ). Fourteen components in 19 batches of SMY, SMC and SMI from different manufacturers were quantitatively determined, including 11 ginsenosides and 3 lignans. The multivariate statistical analysis results further suggested that Rb1, Rg1 and Ro were the main differences among Shengmai preparations. Conclusion The versatile analysis strategy based on HPLC-CAD was simple, convenient, and practical, overcoming the difficulty of weak UV absorption of GR and OR, can reveal the composition and transfer information of SMF and had important guiding significance for improving the quality of Shengmai preparations.