Stress Testing of Pidotimod by LC and LC-MS/MS

Madhuri Baghel^1*, Meenakshi Bharkatiya², Alka Singh³ and Sadhana J. Rajput⁴

¹Apollo College of Pharmacy, Anjora, Durg, Chattisgarh, India.

²B. N. Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India.

³Uttaranchal Institute of Pharmaceutical Sciences, Uttaranchal University, Dehradun, Uttarakhand, India

⁴The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India.

Corresponding Author E-mail: banchhormadhuri@gmail.com

Abstract: 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.

Keywords: Acute respiratory tract infections (ARTIs); LC-MS-MS; Pidotimod; Stability indicating assay method (SIAM); Stress degradation

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