Comparative Evaluation of Protecting Affordability of Flexible Laminates to <i>Bacopa momnnieri</i> Powder Extract

Background: Bacopa monnieri, a medicinal herb, is widely used for its cognitive-enhancing properties. The stability of its active component, Bacoside-A, in commercially available formulations, is influenced by packaging materials. High-Performance Thin-Layer Chromatography (HPTLC) is a reliable technique for the quantification of Bacoside-A. Aim: This study aims to validate the HPTLC method for the quantification of Bacoside-A in commercially available formulations and to evaluate the impact of packaging materials on the stability of these formulations. Methods: The HPTLC method was validated following the ICH Q2 (R1) guidelines. Validation parameters, including linearity (100–500 μg/ml), precision, accuracy, robustness, and sensitivity, were assessed. Stability studies were conducted on commercially available B. monnieri formulations (tablets and powdered extracts) under specific conditions using six different packaging materials. Graphical analysis was used to evaluate degradation trends over time. Results: The validated HPTLC method demonstrated reliability for Bacoside-A quantification. Stability studies revealed degradation over time in both tablet and extract formulations. For powdered extracts, PET-12μ + MET.PET-12μ + MET.CPP (cast polypropylene) and PET-12μ + AL.FOIL-9μ (aluminium foil) was the most effective in preventing degradation. In tablet formulations, PET-12μ + MET.PET-12μ + POLY-85μ and PET-12μ + AL.FOIL-9μ + POLY-62μ provided superior stability. Conclusion: The validated HPTLC method is suitable for the quantification of Bacoside-A in B. monnieri formulations. Major Findings: Stability studies highlight the essential role of suitable packaging materials in reducing degradation and preserving the long-term effectiveness of formulations. Packaging combinations such as PET-12μ + MET.PET-12μ + MET.CPP, PET-12μ + MET.PET-12μ + POLY-85μ, and PET-12μ + AL.FOIL-9μ + POLY-62μ provide enhanced product stability and protection.