Vivek Dhiman, Kanchan S. Patil, Laximan Velip
Oct 7, 2021
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Journal
Rapid communications in mass spectrometry : RCM
Abstract
RATIONALE Stress testing on tinoridine hydrochloride was carried out using a multidimensional approach. This included the hydrolytic (acidic, alkaline and neutral condition), different oxidative reagents, thermal, photolytic conditions, HPLC method development and structure elucidation using high resolution mass spectrometry. It provides the basis for quality control of tinoridine hydrochloride and its derivatives during storage conditions. METHODS The tinoridine hydrochloride was subjected to a variety of stress conditions. A gradient reversed phase HPLC method was developed on X-Bridge C18 column (250 mm x 4.6 mm, 5 μm) column to separate all the degradation products (DPs). High resolution mass spectrometry studies have been performed to elucidate the structure of DPs. RESULTS HPLC-PDA study revealed that significant degradation products were formed in hydrolytic, AIBN (radical initiator at 40 °C), thermal and solid state photolight stress condition, but it was stable to oxidative (H2 O2, Fenton's reagent at roomtemperature and Ferric chloride at 40 °C). Structure of degradation products were elucidated and mechanism of their formation was explained. CONCLUSION Stress study was successfully carried out as per ICH Q1A (R2) guideline on tinoridine hydrochloride. A total of six novel degradation products were characterized, DP 2 and DP 6formed by the effect of co-solvent. This study provides the scientifically sound basis for quality monitoring and its storage conditions.