Abstract
Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC.
 Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm.
 Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%.
 Conclusion: Retention time and total run time of the drug was decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of BLMX.
Highlights
baloxavir marboxil (BLMX), sold under the brand name Xofluza, is an antiviral medication for the treatment of influenza A and influenza B flu [1]
Baloxavir marboxil was developed as a prodrug strategy, with its metabolism releasing the active agent, baloxavir acid (BXA)
Excellent chromatographic efficiency parameters were obtained with the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 %v/v pumped through an HSS C18 (100 x 2.1 mm, 1.8 ) reverse phase column, at a flow rate of 0.3 ml/min
Summary
BLMX, sold under the brand name Xofluza, is an antiviral medication for the treatment of influenza A and influenza B flu [1]. Baloxavir marboxil was developed as a prodrug strategy, with its metabolism releasing the active agent, baloxavir acid (BXA). BXA functions as enzyme inhibitor, targeting the influenza virus’ capdependent endonuclease activity, one of the activities of the virus polymerase complex [2]. It inhibits a process known as cap snatching, by which the virus derives short, capped primers from host cell RNA transcripts, which it uses for the polymerase-catalyzed synthesis of its needed viral mRNAs [3]. A polymerase subunit binds to the host pre-mRNAs at their 5′-caps, the polymerase's endonuclease activity catalyzes its cleavage "after 10–13 nucleotides". Its mechanism is distinct from neuraminidase inhibitors such as oseltamivir and zanamivir
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