Optimization of UV spectrophotometric techniques for tafamidis meglumine detection in pharmaceutical formulations and biological samples: A green chemistry perspective.

OBJECTIVES

The primary objective was to develop and validate four novel UV/visible spectrophotometric methods for the quantification of tafamidis meglumine in bulk drug, proprietary capsules, and spiked urine samples, ensuring accuracy, sensitivity, and environmental sustainability for pharmaceutical analysis.

METHODS

Four spectrophotometric approaches were established using absorbance and area under the curve (AUC) measurements, employing both zero-order and first-order derivative techniques. Method validation followed ICH guidelines, assessing linearity, accuracy, precision, sensitivity (LOD, LOQ), and greenness. Methanol was used as a green solvent, and eco-friendliness was evaluated using AGREE and ComplexGAPI metrics.

RESULTS

All methods exhibited excellent linearity (R2=0.9980-0.9995) over a 3-18μg/mL range. Accuracy was confirmed with recovery rates between 99.00% and 100.57%. Precision studies yielded %RSD values below 2%, indicating high reproducibility. Sensitivity was demonstrated with LOD and LOQ values from 0.27μg/mL to 2.3μg/mL. The use of methanol minimized environmental impact, and high AGREE and ComplexGAPI scores validated the methods' eco-friendly nature.

CONCLUSION

The developed spectrophotometric methods are simple, rapid, sensitive, and environmentally sustainable for quantifying tafamidis meglumine in various matrices. These validated approaches set a new standard for green analytical chemistry in pharmaceutical quality control, ensuring both regulatory compliance and reduced environmental footprint.