Objective To develop and validate a novel ultraviolet (UV)-Vis spectrophotometric method for the simultaneous determination of pregabalin (PG) and duloxetine (DL), addressing PG’s non-chromophoric nature through selective derivatisation and ensuring a sustainable, cost-effective approach suitable for routine quality control. Material and Methods PG was derivatised with ninhydrin in ethanol at 100°C for 5 minutes, forming a stable Ruhemann’s purple complex measured at 580 nm. DL, possessing a native naphthalene chromophore, was directly quantified at 230 nm. The distinct wavelengths eliminated mutual interference. Method validation was performed according to international council for harmonisation(ICH) Q2(R1) guidelines, assessing linearity, accuracy, precision, sensitivity, and specificity. Sustainability was evaluated using AGREE, GAPI, NEMI, Eco-scale, and BAGI tools. Results The method demonstrated excellent linearity (r 2 ≥ 0.9996), high accuracy (mean recovery: 100.57% for PG, 100.58% for DL), and precision (%RSD < 1.2%). Sensitivity was confirmed by low limits of detection (0.549 µg/mL for PG, 0.243 µg/mL for DL). Specificity was verified in synthetic mixtures, and statistical comparison with a reference method confirmed equivalence. The green profile was affirmed by multiple sustainability assessment tools. Conclusion The proposed UV-Vis spectrophotometric method is simple, selective, accurate, precise, and environmentally friendly. Its validated performance and sustainability profile make it highly suitable for routine quality control of PG and DL in pharmaceutical analysis.
Abdallah et al. (Thu,) studied this question.