Development and Validation of HPLC-UV Method for the Determination of Favipiravir in Human Plasma

Abstract

Introduction. Coronavirus disease (COVID-19) is an acute infectious disease caused by SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2). Favipiravir is a synthetic prodrug with antiviral activity used for the treatment of COVID-19. There are oral and parenteral dosage forms of favipiravir. Compared with oral administration, parenteral administration has some advantages. Developing a method for the determination of favipiravir in human blood plasma is necessary for performing the analytical part of clinical studies of favipiravir for parenteral administration as an infusion, studying pharmacokinetics, and choosing the optimal dosage of the drug.Aim. The aim of this study is to develop and validate a method for quantitative determination of favipiravir in human plasma by high-performance liquid chromatography with ultraviolet detection (HPLC-UV) for pharmacokinetic studies.Materials and methods. Determination of favipiravir in human plasma by HPLC-UV. The UV detection was set at 323 ± 2 nm. The samples were processed by methanol protein precipitation. Internal standard: raltegravir. Mobile phase: 0.1 % formic acid in water with 0.08 % aqueous ammonia (eluent A), 0.1 % formic acid in acetonitrile with 0.08 % aqueous ammonia (eluent B). Column: Phenomenex Kinetex®, C18, 150 × 4.6 mm, 5 μm. Analytical range: 0.25–200.00 μg/mL.Results and discussion. This method was validated by selectivity, calibration curve, accuracy, precision, spike recovery, the lower limit of quantification, carry-over effect and stability.Conclusion. We developed and validated the method of quantitative determination of favipiravir in human plasma by HPLC-UV. The analytical range was 0.25–200.00 μg/mL in human plasma. The method could be applied in pharmacokinetics studies of favipiravir.

Fast Track Surgery as the Latest Multimodal Strategy of Enhanced Recovery after Urethroplasty

“…An excellent result is considered a signifcant decrease in the severity of post-operative pain (p < 0.001), and, consequently, a decrease in surgical stress, as well as a reduction in the treatment period, from the moment of diagnosis to full recovery (p < 0.001) when using the developed FTS protocol. Te authors did not fnd similar studies of the efectiveness of FTS in urethroplasty; however, the general concept of the system and many works [35][36][37][38][39][40][41] demonstrate similar results.…”

Insights into the sustainability of liquid chromatographic methods for favipiravir bioanalysis: a comparative study

“…Several analytical techniques have been utilized to analyze favipiravir, including spectrophotometry, [7][8][9] spectrouorimetry, [10][11][12] high performance liquid chromatographyultraviolet detector (HPLC-UV), [13][14][15][16] capillary electrophoresis, 17 liquid chromatographytandem mass spectrometry (LC-MS/MS) [18][19][20][21][22] and high performance thin liquid chromatography (HPTLC). 16 These methods have been applied to pharmaceutical dosage forms 7,8,11 and biological uids such as plasma, [13][14][15][16]18,19,21,[23][24][25][26][27][28][29][30] serum, 20,[31][32][33] and milk. 29 Green Analytical Chemistry (GAC) has gained attention since 2000, with the goal of establishing safe analytical methodologies for both individuals and the environment.…”

“…Several analytical techniques have been utilized to analyze favipiravir, including spectrophotometry, 7–9 spectrofluorimetry, 10–12 high performance liquid chromatography – ultraviolet detector (HPLC-UV), 13–16 capillary electrophoresis, 17 liquid chromatography – tandem mass spectrometry (LC-MS/MS) 18–22 and high performance thin liquid chromatography (HPTLC). 16 These methods have been applied to pharmaceutical dosage forms 7,8,11 and biological fluids such as plasma, 13–16,18,19,21,23–30 serum, 20,31–33 and milk. 29…”

Development and Validation of a High-Performance Liquid Chromatography with Tandem Mass Spectrometry (HPLC-MS/MS) Method for Quantification of Major Molnupiravir Metabolite (β-D-N4-hydroxycytidine) in Human Plasma

“…The morbidity and mortality rates have reached extremely high values globally [ 2 ]. According to statistics, as of April 2023, over 762 million SARS-CoV-2 virus cases were confirmed worldwide, of which about 6.9 million resulted in fatalities [ 3 , 4 ]. Although vaccination has played a significant role in reducing viral spreading, some populations remain unvaccinated.…”