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Detection of potential degradants in Oseltamivir by Liquid Chromatography-Tandem Mass Spectroscopy

. Jane Mathew and Neethu Mathew V


Abstract

Objectives: A sensitive and reliable Liquid Chromatography and Mass Tandem Spectroscopy method was developed for the detection of possible degradants in Oseltamivir. The rationale behind this study was to identify the degradants present in Oseltamivir that could pose risk to patient at the far end by early detection. Degradants can appear at any stage from the starting of raw material collection through the entire process of synthesis ,manufacture ,formulation and storage. Oseltamavir is subjected to forced degradation studies like thermal and oxidative stress. Materials and methods: The Thermal degradation study was carried out in solid state by exposing Oseltamivir in a petri plate as a very thin layer to dry heat in the oven at 105â—¦C for 12 hrs. Peroxide degradation was carried out by treating the drug with 10mL of 3% Hydrogen peroxide and kept it on a bench for 2 hrs.  Oseltamivir standard and test solution samples were prepared and analyzed by using LC-MS/MS method. Results and discussion: Liquid chromatogram showed retention time at 0.731, 0.723 and 0.714 minutes for standard and test solutions respectively. The mass spectral data are presented with a mass range of 100-600 m/z on (x-axis) and intensity on (y-axis). The obtained mass spectral data revealed that the peak intensity of API and stressed samples have no significant difference. Conclusion:The antiviral drug Oseltamivir remained unaffected under stress degradation conditions of both peroxide and thermal based on the observed LC-MS/MS spectral evidence, it proved that the inherent stability of the Oseltamivir under stress condition to be good.

Keywords: Oseltamavir, forced degradation,LC-MS/MS

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