2021
DOI: 10.13005/ojc/370525
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Method Development and Validation for the Trace Level Quantification of Genotoxic Impurity Oseltamivir Phosphate Related Compound-a in Oseltamivir Phosphate Using LC-MS

Abstract: A selective and sensitive method has been developed for the determination of ethyl-(3S,4R,5S)-4-acetamido-5-amino-2-azido-3-(pentan-3-yloxy)cyclohexanecarboxylate (OSPRC-A) by using liquid chromatography coupled with mass spectrometer with single mass analyzer (LC-MS).The method was developed by using column DEVELOSIL ODS-UG-5, (50×3.0 mm, 5.0 µm) with linearity range of 0.005% to 0.0151% which meets to quantification level of 150% range. The column oven temperature was maintained at 40ºC. The flow rate was se… Show more

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