eng Oriental Scientific Publishing Company Biomedical and Pharmacology Journal 0974-6242 2024-03-20 17 1 517 526 10.13005/bpj/2878 56101 article Madhuri Baghel 1 Meenakshi Bharkatiya 2 Alka Singh 3 Sadhana J. Rajput 4 Apollo College of Pharmacy, Anjora, Durg, CG. B. N. Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun, Uttarakhand, India The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India Pidotimod is a synthetic biological and immunological modulator with dipeptide structure. It has been used for a long time to treat and prevent recurring respiratory infections. .Pidotimod stress testing and degradation profiling were carried out under ICH-recommended stress degradation protocols. To resolve Pidotimod and its impurities, the degradation products generated by various stress conditions were combined and separated on RP-C-18 column. LC-MS-MS study revealed existence of nine degradation products, six of which were previously unknown. On the basis of m/z values, degradation pathways for degradation products generated after stress testing were postulated. https://biomedpharmajournal.org/vol17no1/stress-testing-of-pidotimod-by-lc-and-lc-ms-ms/ Acute respiratory tract infections (ARTIs) LC-MS-MS Pidotimod Stability indicating assay method (SIAM) Stress degradation