Method and system for detecting impurities in flunarizine hydrochloride bulk drug

By combining empirical mode decomposition and baseline optimization in preprocessing, and integrating continuous wavelet transform and Gaussian-Logistic distribution function convolution model, the problems of chromatographic peak overlap and noise interference in the detection of trace impurities in flunarizine hydrochloride raw material were solved, and high-precision impurity quantification was achieved.

CN122306995APending Publication Date: 2026-06-30ZHENGZHOU RUIKANG PHARM CO LTD
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Patent Information

Application Number
CN202610585338.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-04-29
Publication Date
2026-06-30

AI Technical Summary

Technical Problem

Existing technologies for detecting trace impurities in flunarizine hydrochloride raw materials suffer from problems such as chromatographic peak overlap, noise interference, and baseline drift, leading to inaccurate quantification. Traditional methods cannot effectively constrain the degree of peak overlap and morphological differences, resulting in failure to quantify trace impurities.

Method used

Empirical mode decomposition is used to denoise the model, and a baseline optimization algorithm is used to generate a denoised chromatogram. The optimal analysis scale is determined by the signal-to-noise ratio metric. Continuous wavelet transform is used to identify the number of components. A convolution model of Gaussian function and modified Logistic distribution function is established, and a trust region reflection algorithm is used for nonlinear iterative fitting. A penalty regularization term is added to optimize the model parameters.

Benefits of technology

This method enables high-precision detection of trace impurities in flunarizine hydrochloride raw material, filters out complex noise, accurately identifies overlapping peaks, improves quantitative accuracy and reliability, and avoids non-physical analysis and errors of traditional methods.

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Abstract

The invention provides a method and a system for detecting impurities in flunarizine hydrochloride bulk drug, the detection method comprises the following steps: acquiring an original chromatographic signal, and performing empirical mode decomposition denoising and baseline optimization to obtain a baseline corrected and denoised chromatogram; determining a signal-to-noise ratio according to an energy relationship between noise and signals in preprocessing, determining an optimal analysis scale through a preset function, screening ridge lines through continuous wavelet transform to determine the number of chromatographic peak components, and extracting initial model parameters; a mathematical model of the convolution of a standard Gaussian function and a modified Logistic distribution function is established for each component peak, nonlinear iterative fitting is carried out by adopting a trust region reflection algorithm, and an objective function comprises a least square residual term and a weighted regularization term; and after the objective function is converged, obtaining an optimal model parameter, and calculating the peak integral area of each impurity component to determine the content.
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