Development of Quantitative Fingerprint Method for Dabuyin Pills(Concentrated Pills) Based on the AQbD Concept

OBJECTIVE To establish a quantitative fingerprint analysis method for the simultaneous determination of 4 components, namely 5-hydroxymethylfurfural, 3-O-feruloylquinic acid, neomangiferin and berberine hydrochloride, in Dabuyin Pills(concentrated pills) based on the concept of analytical quality by design, using high performance liquid chromatography-ultraviolet detection.

METHODS Firstly, potential critical method parameters(CMPs) were identified. Then, critical method attributes(CMAs) were distinguished through definitive screening design. Subsequently, quantitative relationship models between CMPs and CMAs were established using stepwise regression. The method operable design region(MODR) was established by the Monte Carlo method and successfully verified. The robustness of the analytical method was evaluated using the Plackett-Burman design.

RESULTS The established operable design region based on the analytical method for these 4 components was reliable, and the method exhibits favorable robustness. The similarity values between different batches of Dabuyin Pills(concentrated pills) and between each batch and the reference fingerprint were all greater than 0.95, indicating that the consistency among different batches of Dabuyin Pills(concentrated pills) was good.

CONCLUSION This method has good durability and has been verified by methodology, and can be used for the determination of the contents of 4 components in Dabuyin Pills(concentrated pills).