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- W3202714128 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 × 4.6 mm, 5 μm) 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." @default.
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- W3202714128 date "2021-11-21" @default.
- W3202714128 modified "2023-09-25" @default.
- W3202714128 title "Comprehensive degradation profiling and influence of different oxidizing reagents on tinoridine hydrochloride: Structural characterization of its degradation products using HPLC and HRMS" @default.
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- W3202714128 doi "https://doi.org/10.1002/rcm.9210" @default.
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