Development, Validation, and Stability Assessment of High-performanceLiquid Chromatography Method for Rotigotine in PharmaceuticalApplications

Introduction: This study aimed to develop and validate a stability-indicating HPLC method for the quantification of Rotigotine, a dopamine receptor agonist used in the treatment of Parkinson’s disease, in compliance with ICH Q2(R1) guidelines. Methods: Chromatographic separation was achieved on a Shim-pack Solar C8 column (4.6 × 250 mm, 5 µm) using a mixture of acetonitrile and phosphate buffer (60:40, pH 4.5) with UV detection at 224 nm. Validation parameters included linearity, accuracy, precision, robustness, sensitivity, forced degradation studies, stability testing, and artificial plasma spiking. Results: The method was linear (1–15 µg/mL, r² = 0.9996) with high precision (%RSD < 0.5) and accuracy (98–102% recovery). LOD and LOQ were 0.575 µg/mL and 1.742 µg/mL, respectively. Forced degradation revealed significant instability under alkaline (39.22%) and oxidative (34.44%) stress, moderate degradation in acidic medium (15.1%), and minimal photolytic degradation (3.62%). Stability studies showed unacceptable degradation beyond 12 hours at room temperature. Plasma spiking confirmed applicability with recoveries up to 88.5% Discussion: The method demonstrated high sensitivity, reproducibility, and stability-indicating capability, highlighting Rotigotine’s vulnerability to alkaline and oxidative environments while confirming light stability and moderate acid sensitivity. Plasma recovery supports pharmacokinetic application. Conclusion: The validated HPLC method is robust and reliable for routine quality control, stability testing, and pharmacokinetic evaluation of Rotigotine, with storage conditions requiring strict control to maintain drug integrity