Development and Validation of Stability Indicating RP-HPLC Method for Determination of Safinamide Mesylate

Vaibhav S. Adhao, Raju R. Thenge, J. Sharma, M. Thakare


A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Safinamide Mesylate. In the present study, stress testing of Safinamide Mesylate was carried out according to ICH guidelines Q1A (R2). Safinamide Mesylate was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using Methanol: Phosphate Buffer pH 6.8 (80:20 % v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Higher degradation was found to occur in acidic, alkaline, oxidative and photolytic condition. Lesser degradation was observed at thermal conditions. Quantification and linearity was achieved at 226 nm over the concentration range of 40 - 180 μg/mL for Safinamide Mesylate. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.The developed method is suitable for the routine analysis as well as stability studies.


Stability-indicating, HPLC, Safinamide Mesylate, Validation, Stress Testing

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