Affiliation:
1. Department of Pharmaceutical Chemistry Sinhgad Institute of Pharmacy Savitribai Phule Pune University Pune Maharashtra India
2. Department of Pharmaceutical Chemistry Vishwakarma University School of Pharmacy Pune Maharashtra India
3. Department of Pharmaceutical Chemistry Sinhgad Institute of Pharmaceutical Sciences Lonavala Maharashtra India
4. Department of Pharmaceutical Chemistry Goa College of Pharmacy Panaji Goa India
5. Department of Pharmaceutical Analysis Goa College of Pharmacy Panaji Goa India
Abstract
AbstractThe objective of the present research work was to demonstrate the application of liquid chromatography coupled with tandem mass spectrometry (LC‐MS/MS) for the separation, identification, and characterization of degradation products (DPs) of the drug lobeglitazone. The drug was subjected to various stress conditions such as oxidation, hydrolysis, thermal, and photolytic degradation as per the guidelines of the International Conference on Harmonization Q1A (R2). The drug was stable under thermal stress conditions, whereas it was susceptible to degradation in the other stress conditions forming four DPs. DPs were separated using a high‐performance LC system equipped with Zorbax SB C18 column (250 × 4.6 mm, 5 µm particles) using isocratic elution mode. The DPs were identified and characterized using MS and MS/MS. The chemical structure and fragmentation pattern were predicted for each degradant from the data obtained by mass studies. The drug and identified DPs were assessed by in‐silico approaches for predicting absorption, distribution, metabolism, and toxicity behavior. The in‐silico tools used for prediction were the pkCSM web server, ToxTree, and OSIRIS property explorer.
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