Stability Indicating UV Spectroscopy of Rizatriptan Benzoate by QbD Approach and Green Chemistry Principles: Sustainable Analytical Method Development

The present study describes the development and validation of QbD-assisted UV-Visible spectrophotometric methods for the quantitative determination of rizatriptan benzoate. The spectrophotometric determination was performed between 200–400 nm and the absorbance was compared to the wavelength. The developed method was validated according to the ICH guidelines for specificity, linearity, precision, accuracy, ruggedness, robustness, repeatability, forced degradation studies, and greenness assessment. The precision of the developed method was evaluated by calculating the percentage relative standard deviation (%RSD). The obtained %RSD values were within the acceptable limits specified by regulatory guidelines, confirming the method’s satisfactory precision and reliability for routine analytical applications. The accuracy of the developed method was evaluated and expressed as the percentage mean recovery which demonstrates the closeness of agreement between the measured and true values. The greenness of the developed UV spectroscopic method was evaluated using the Green analytical procedure index (GAPI), Blue applicability grade index (BAGI) and the AGREE tool, confirming compliance with green analytical chemistry principles. The method was developed and validated in accordance with the International Council for Harmonisation (ICH) guidelines for pharmaceuticals for human use. The validation parameters demonstrated satisfactory performance characteristics. The proposed method was successfully applied to the quantitative analysis of rizatriptan benzoate.

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