2025, Vol. 5, Issue 2, Part B

Methods: Quantification was carried out using distilled water as the solvent, with maximum absorbance at 204 nm for both zero-order and first-order spectra. Linearity was observed over 9-45 µg/mL, yielding correlation coefficients (r²) of 0.9998 (zero-order) and 0.9999 (first-order). Forced degradation studies were performed under acidic, alkaline, oxidative, reductive, thermal, photolytic, and UV stress for the zero-order method.

Results: The method exhibited excellent linearity, accuracy, and precision, with % RSD <2% in intra-day and inter-day studies. LOD and LOQ were 1.5986/4.8443 (zero-order) and 0.8539/2.5877 (first-order). Plecanatide degraded under acidic and reductive conditions but remained stable under other stress conditions. Conclusion: The validated method is simple, precise, accurate, and suitable for routine plecanatide analysis.