Forced Degradation Studies, Method Development and Validation Of RP-HPLC Method For the Analysis of Plecanatide in Bulk and Tablet Dosage Form

Objective: To develop and validate a novel, simple, accurate, precise, and stability-indicating RP-HPLC method for the estimation of Plecanatide in bulk and tablet formulation, including forced degradation studies. Methods: The chromatographic separation was achieved using a C18 column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of water and acetonitrile (50:50 v/v) with 0.05% trifluoroacetic acid (TFA) at a flow rate of 0.8 mL/min, with UV detection at 204 nm. The method was validated as per ICH guidelines for linearity, precision, accuracy, ruggedness, robustness, LOD, and LOQ. Forced degradation studies were conducted under acidic, alkaline, oxidative, reductive, thermal, photolytic, and UV light conditions to evaluate the stability-indicating nature of the method. Results: Plecanatide showed a sharp and symmetric peak with a retention time of 3.092 minutes. The method was linear in the concentration range of 6-30 µg/mL with a correlation coefficient (r² = 0.9999). Precision results (% (RSD) were below 2%, and recovery values ranged from 99.55% to 101.00%, confirming accuracy. LOD and LOQ were found to be 0.7324 µg/mL and 2.2195 µg/mL, respectively. Forced degradation studies indicated significant degradation under acidic and reduction conditions, while the drug was relatively stable under alkaline, oxidation, photolytic, thermal, and UV light stress. Conclusion: The developed RP-HPLC method is simple, precise, accurate, and stability-indicating. It is suitable for routine quality control, stability testing, and degradation behavior studies of Plecanatide in bulk and tablet dosage form.