Stability Indicating LC-DAD Method for Determination of Nadifloxacin and Characterization of Its Degradation Products by LC–ESI–MS/MS

Salunke, Nishant; Pandita, Nancy

doi:10.1007/s10337-018-3468-6

Cited by 6 publications

(1 citation statement)

References 5 publications

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“…DP 2 was formed in the presence of co‐solvent (acetonitrile) through a two‐step reaction: (i) Ritter reaction, followed by (ii) a new bond formation between amine and electron‐deficient carbon of nitrile 13–16 . DP 3 was formed by aromatic hydroxylation in the acidic condition, which was observed in the case of nadifloxacin 17 . It was also reported as the aromatic hydroxyl metabolite of tinoridine hydrochloride 5 .…”

Section: Degradation Pathway Of Dp 1 To Dpmentioning

confidence: 99%

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

Dhiman

Patil

Velip

et al. 2021

Rapid Comm Mass Spectrometry

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Rationale 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. Methods 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. 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 conditions, but the drug was stable under oxidative conditions (H2O2, 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. Conclusion 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.

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Section: Degradation Pathway Of Dp 1 To Dpmentioning

confidence: 99%