Strategic development and validation of a stability-indicating analytical method for S-adenosylmethionine
DOI:
https://doi.org/10.56782/pps.572Keywords:
S-adenosylmethionine, method development, forced degradation, pharmaceutical analysis, RP-HPLCAbstract
S-Adenosylmethionine (SAMe) is a biologically essential compound involved in DNA methylation, liver detoxification, neurotransmitter synthesis, and joint health. Due to its instability and susceptibility to degradation, a validated analytical method is crucial for its accurate quantification and quality control. This research focuses on the development, validation, and stability assessment of a refined RP-HPLC method for the quantification of S-adenosylmethionine (SAMe) in both bulk material and pharmaceutical formulations. The method development involved selecting an appropriate mobile phase and wavelength, optimizing chromatographic conditions, and validating the method according to the standards outlined in International Conference on Harmonisation (ICH Q2R1). Forced degradation experiments were carried out under thermal, photolytic, acid, base, and oxidative stress conditions to assess stability. The optimized RP-HPLC method, with a mobile phase of ACN/0.1% OPA aqueous solution (20:80, v/v) and a detection wavelength of 259 nm, demonstrated high precision, linearity (R² = 0.99996), and accuracy (recovery between 98-102%). The method effectively detected degradation products, establishing the method’s capability to indicate stability. The optimized RP-HPLC method demonstrated simplicity, accuracy, precision, and robustness for the quantitative analysis and stability evaluation of S-adenosylmethionine (SAMe). It is well-suited for quality control applications and aligns with regulatory standards, offering a reliable tool for routine analysis of SAMe in pharmaceutical formulations.
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Copyright (c) 2025 Mayur S. Bhamare, Ganesh B. Sonawane , Vijayraj N. Sonawane , Chandrashekar D. Patil, Rushikesh L. Bachhav, Sunil K. Mahajan, Dipak D. Sonawane
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