Evaluation and Degradation Chemistry of Orbifloxacin using LC-MS

Evaluation and Degradation Chemistry of Orbifloxacin using LC-MS

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Author(s)

Author(s): Edith Cristina Laignier Cazedey, Sanjay Garg, Herida Regina Nunes Salgado

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474 1213 11-20 Volume 2 - Sep 2013

Abstract

Orbifloxacin (ORBI) was subjected to different ICH (Q1A(R2)) prescribed stress conditions of thermal stress, hydrolysis, oxidation and photolysis. It was stable to dry heat (60 ºC) and photolysis (UV-VIS) in solid form. It showed extensive decomposition under hydrolytic and photolytic conditions in acid, base and neutral solutions. Degradation was also observed in oxidative condition. Degradation products of ORBI formed under different forced conditions were characterized through LC–MS studies. In total, eleven major degradation products (DP1-DP11) were detected. Successful separation of drug and degradation products formed under various stress conditions was achieved on a analytical column SymmetryShield Waters RP18, 5 µm, 250 x 4.6 mm using 5% acetic acid and methanol as mobile phase in a gradient mode at flow rate of 0.5 ml/min. The peaks were detected using a PDA detector set at 290 nm. The method was extended to LC–APCI-MS for characterization of the degradation products and the pathways of decomposition were proposed.

Keywords

Orbifloxacin, Chemistry degradation, SIAM, LC-APCI-MS, Stability

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International Journal of Sciences is Open Access Journal.
This article is licensed under a Creative Commons Attribution 4.0 International (CC BY 4.0) License.
Author(s) retain the copyrights of this article, though, publication rights are with Alkhaer Publications.

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