Abstract
Background: Trigonelline is an alkaloid known for its therapeutic potentials. The present study aims to develop a stability-indicating, Quality by Design-based eco-friendly UV spectroscopic method for the estimation of trigonelline in nanoformulation. Methodology: Water was used as the principal solvent. The method was optimized using a design of experiments approach. Critical process parameters were identified as sonication time and scanning interval, while absorbance was designated as the critical quality attribute. The optimized parameters (10-minute sonication time and low scanning interval) were validated according to ICH guidelines. A forced degradation study was also conducted. Results: A linear relationship was confirmed at concentrations ranging from 5 to 25 μg/ml, with an R2 value of 0.999 at 265 nm. The precision assays showed a %RSD of less than 2, indicating high precision. The recovery percentages ranged from 99.56% to 101.85%, indicating reliable accuracy. The method revealed LOD and LOQ values of 0.66 μg/mL and 2.00 μg/mL, respectively, underscoring its sensitive characteristics. The method demonstrated both rugged and robust characteristics. The assays for acidic, basic and oxidative stability indicated a degradation range of 24.84% to 35.95%, while thermal degradation exhibited a significant degradation level of 51.23%. The developed UV spectroscopic method successfully quantified trigonelline in the nanoformulation. Conclusion: This QbD-driven UV spectroscopic method provides a valuable tool for trigonelline analysis in nanoformulation, offering rapid analysis, high accuracy with low detection limits.
Published Version
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