Abstract

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Favipiravir and Peramivir and their related substances.
 Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Favipiravir and Peramivir. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 260 nm utilizing the PDA detector was given in the instrumental settings. Using the impurity-spiked solution, the chromatographic approach was streamlined.
 Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients and their impurities were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, which means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness was determined as a part of method validation and the results were found to be within the acceptable range.
 Conclusion: The proposed method to be fast, simple, feasible and affordable in RS condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.

Highlights

  • IntroductionPeramivir (trade name Rapivab) is an antiviral medication developed for the treatment of influenza by BioCryst pharmaceuticals [1]

  • Peramivir is an antiviral medication developed for the treatment of influenza by BioCryst pharmaceuticals [1]

  • Rapiacta, which is provided by intravenous drip injection, was one of them [4,5,6]

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Summary

Introduction

Peramivir (trade name Rapivab) is an antiviral medication developed for the treatment of influenza by BioCryst pharmaceuticals [1]. In October 2009, the experimental antiviral drug peramivir was confirmed to be “life saving” effective in the intravenous treatment of 8 extreme cases of swine flu [2]. S. An emergency use authorization for peramivir was provided bt the Food and Drug Administration (FDA), authorizing the use of the drug in intravenous form for hospitalized parents only in cases where the other treatment options available are inadequate or unavailable [3]. Peramivir was the first intravenous neuraminidase inhibitor (NAI) approved by the US food and drug administration (FDA) for the treatment of influenza [7]. Favipiravir, sold under the brand name Avigan among others, is an antiviral medication used to treat influenza in Japan [12]. Research in 2014, suggested that Favipiravir may have efficacy in humans, it went unaddressed

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