LAUSR

BACKGROUND Peramivir, a neuraminidase inhibitor that serves as a transition-state analogue for influenza, inhibiting the formation of new viruses in infected cells and also been approved for intravenous administration. OBJECTIVE To validate the HPLC method to identify the degraded products of the antiviral drug Peramivir. METHODS Herein, we report the identification of degraded compounds formed after the degradation of the Peramvir an antiviral drug done by the acid, alkali, peroxide, thermal and photolytic degradation. At the level of toxicology, a technique was devised for the isolation and measurement of the compound known as peramivir. RESULTS A sensitive and reliable liquid chromatography-tandem mass spectrometry technique to the quantitative measurement of Peramivir and also its impurities was developed and verified in order to comply with the recommendations made by ICH. The proposed protocol was in the 50-750 µg/mL range. RSD values less than 2.0% indicate good recovery in the range of 98.36%-102.57%. Within the studied range, the calibration curves demonstrated good linearity, in addition, the coefficient of fitting correlation was more than 0.999 for every impurity. Contaminant quantitative analysis revealed the high efficiency at a low level. CONCLUSION Given its ability to separate degradation products, quantitative analysis is used to detect and quantify known and unknown impurities and degradants in the Peramivir drug substance during routine analysis and stability studies. No significant degradation was found in peroxide and photolytic degradation studies. HIGHLIGHTS An HPLC method was developed and put to the test in order to analyse the behavior of the impurities of peramivir as they degraded when subjected to the stress conditions suggested by the ICH.The compound was discovered to be stable under peroxide and photo conditions but degradable towards the acid, base and thermal. The method developed was extremely precise, linear, accurate, robust, and rugged.As a result, this technology has the potential to be used in the medication production process for regular impurity analysis as well as for the stability analysis of peramivir.