Development and Validation of RP–HPLC With Diode‐Array Detection–Based Method for Simultaneous Estimation of Berberine and Bromocriptine: Application in Formulation Development and Pharmacokinetic Studies in Parkinson's Disease

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Abstract
Berberine (BBR) and bromocriptine (BM) exhibit significant therapeutic potential for neurodegenerative diseases, including Parkinson's disease; however, their clinical application is limited by poor stability, rapid clearance, and lack of unified platform for simultaneous evaluation. This study developed and validated a simple, reliable, and economical RP–HPLC with diode‐array detection–based method for their simultaneous quantification, adhering to ICH and US FDA guidelines. The method demonstrated excellent selectivity, linearity, precision, accuracy, and reproducibility and was successfully translated into bioanalytical method for plasma analysis. Forced degradation studies validated the method's ability to indicate stability under acidic, alkaline, oxidative, and thermal stress conditions. Polydopamine (PDA) nanoparticles (NPs) were developed to co‐encapsulate BBR and BM, exhibiting favorable physicochemical characteristics, high drug loading, and sustained in vitro release following diffusion‐controlled kinetics. Overall, the validated analytical and bioanalytical method verified its versatility across formulation development, stability assessment, release kinetics, and pharmacokinetic studies, whereas the PDA NP system demonstrated sustained delivery and improved pharmacokinetic performance, supporting its potential for further preclinical and pharmacodynamic studies for various neurodegenerative diseases.

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