Comprehensive degradation profiling and influence of different oxidizing reagents on tinoridine hydrochloride: Structural characterization of its degradation products using HPLC and HRMS.

Abstract

Stress testing on tinoridine hydrochloride was carried out using a multidimensional approach. This included different conditions: hydrolytic (acidic, alkaline, and neutral conditions), different oxidative reagents, thermal, photolytic conditions, HPLC method development, and structural elucidation using high-resolution mass spectrometry (HRMS). It provides the basis for quality control of tinoridine hydrochloride and its derivatives during storage conditions. The tinoridine hydrochloride was subjected to a variety of stress conditions. A gradient reversed-phase HPLC method was developed on a X-Bridge C18 column (250 × 4.6mm, 5μm) to separate all the degradation products (DPs). HRMS studies have been performed to elucidate the structure of DPs. HPLC-PDA study revealed that significant degradation products were formed in hydrolytic, AIBN (radical initiator at 40°C), thermal, and solid-state photolight stress conditions, but the drug was stable under oxidative conditions (H2 O2, Fenton's reagent at room temperature and ferric chloride at 40°C). The structure of degradation products was elucidated, and mechanism of their formation was explained. Stress study was successfully carried out as per ICH Q1A (R2) guideline on tinoridine hydrochloride. A total of six new degradation products were characterized, DP 2 and DP 6 formed by the effect of co-solvent. This study provides the scientifically sound basis for quality monitoring and storage conditions of tinoridine hydrochloride.