Investigation of anti-Hepatitis C virus, sofosbuvir and daclatasvir, in pure form, human plasma and human urine using micellar monolithic HPLC-UV method and application to pharmacokinetic study

Zidan, Dalia W.; Hаssаn, Wаfаа S.; Elmasry, Manal S.; Shalaby, Abdalla

doi:10.1016/j.jchromb.2018.04.011

Cited by 16 publications

(8 citation statements)

References 17 publications

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“…The most prevalent stationary‐phase columns consisted of long carbon chains (C 18 ) bound to silica, with a length of 150–250 mm and particle size 3–5 μm (Abdel‐Gawad, 2016; Hassouna & Mohamed, 2018; Miraghaei et al, 2017; Nekkala et al, 2018; Rathod et al, 2018; Sandya Rani & Devanna, 2018; Saroja et al, 2018). The use of the C 8 column was also reported for the analysis of sofosbuvir (Baker et al, 2018; Bhavsar et al, 2018; Zidan et al, 2018).…”

Section: Hplc Methods For the Analysis Of Sofosbuvirmentioning

confidence: 95%

“…The optimum chromatographic separation could be achieved in most of the reported methods via ACN due to its low viscosity and low ultraviolet (UV) cut‐off wavelength (Atia et al, 2018). The addition of hexane sulfonate (Hassouna & Mohamed, 2018) and triethylamine (EL‐Shorbagy et al, 2019; Fares et al, 2019; Mastanamma et al, 2018; Sathiya & Badeliya, 2018; Zidan et al, 2018) was employed to improve the separation process and overcome the peak tailing problems. Acidic buffers were used to increase the ionization of sofosbuvir, a basic analyte, which in turn decreased the affinity of sofosbuvir for the stationary phase and reduced the retention time (EL‐Shorbagy et al, 2019).…”

Section: Hplc Methods For the Analysis Of Sofosbuvirmentioning

confidence: 99%

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Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Abdel-Tawab

El-Moghny

Nashar

2021

Biomedical Chromatography

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Sofosbuvir is a direct‐acting antiviral drug that inhibits hepatitis C virus (HCV) NS5B polymerase, which in turn affects the virus replication inside biological systems. The clinical importance of sofosbuvir is based not only on its effect on HCV but also on other lethal viruses such as Zika and severe acute respiratory syndrome coronavirus disease 2019 (SARS‐COVID‐19). Accordingly, there is a continuous shedding of light on the development and validation of accurate and fast analytical methods for the determination of sofosbuvir in different environments. This work critically reviews the recent advances in chromatographic methods for the analysis of sofosbuvir and/or its metabolites in pure samples, pharmaceutical dosage forms, and in the presence of other co‐administered drugs to highlight the current status and future perspectives to enhance its determination in different matrixes.

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Section: Hplc Methods For the Analysis Of Sofosbuvirmentioning

confidence: 95%

Section: Hplc Methods For the Analysis Of Sofosbuvirmentioning

confidence: 99%

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Abdel-Tawab

El-Moghny

Nashar

2021

Biomedical Chromatography

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“…Forced degradation studies [18][19][20][21][22] Stock solutions prepared by dissolving 10 mg of daclatasvir working standard into a 10 mL diluents. Table 2 shows degradation data of daclatasvir.…”

Section: Limit Of Quantificationmentioning

confidence: 99%

Validated Stability Indicating HPLC Method for Estimation of Daclatasvir

2019

Chem Sci Trans

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For the determination of daclatasvir from formulation, a new, simple, specific, accurate and robust isocratic reversed-phase (RP) stability indicating high-performance liquid chromatographic (HPLC) method has been developed and validated. The liquid chromatographic separation isocratically accomplished by means of a portable acetonitrile, buffer (0.1% Octa sulphonic acid) (70:30). The analysis was carried out using at ambient temperature on Xterra C 18 (4.6x150 mm, 5.0 µm) at flow rate of 1 mL/min and the UV detection at 237 nm. The method was validated for accuracy, precision, linearity, range, selectivity and robustness. The linearity of the proposed method was investigated in the range of 20 to 100 µg/mL (r 2 = 0.999). The drug was subjected to oxidation, hydrolysis, heat and photolysis to apply stress conditions. The method provided good peak parameters with retention time of 2.398 min. Degradation products resulting from stress studies did not interfere with the detection of daclatasvir and the assay can thus be considered as stability-indicating HPLC method.

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“…The reported analytical methods for determination of VAR include liquid chromatography [6][7][8][9][10][11], gas chromatography [12], atomic emission spectrometry [13], capillary electrophoresis [14], voltammetric methods [15][16][17] and different spectroscopic methods [18][19][20][21][22][23][24][25]. In addition, several methods were reported for quantitative determination of DAC either alone or simultaneously with the other newly approved drugs including different chromatographic methods [26][27][28][29], stability indicating HPLC studies in bulk and formulations [30][31][32][33], electrochemical methods [34][35][36], spectrofluorimetric methods [37][38][39] and thin layer chromatographic method [40].…”

Section: Introductionmentioning

confidence: 99%

Pencil Graphite Electrode Decorated with Xylenol Orange Flakes for Studying Possible Pharmacokinetic Interaction Between Vardenafil and Daclatasvir

et al. 2019

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The main aim of the current work is to investigate possible pharmacokinetic interactions between vardenafil hydrochloride (VAR), which is used for the treatment of erectile dysfunction and daclatasvir dihydrochloride (DAC), which is used for the treatment of chronic hepatitis C viral infection when they are concomitantly administered. Therefore, a sensitive and selective square‐wave voltammetric method was developed and validated for simultaneous determination of VAR and DAC using disposable pencil graphite electrode (PGE) modified with xylenol orange (X.O.) flakes as an electrochemical sensor. A full investigation of the experimental parameters for obtaining the highest electroanalytical signal with sufficient resolution between the oxidation peaks of two compounds was performed. It was found that VAR and DAC were resolved on X.O./PGE with different potentials at 1.4 V and 0.9 V, respectively using Britton‐Robinson buffer (pH 2.2) and 0.1 mol L−1 KCl as a supporting electrolyte. In addition, with the aid of cyclic voltammetry, a mechanistic scheme for the oxidation behaviour of both VAR and DAC was suggested. The proposed square wave voltammetric method was successfully applied for trace quantification of VAR and DAC in male rabbits. The suggested approach shows detection and quantification limits in rabbit plasma samples of 0.06 and 0.17 μmol L−1, respectively for VAR and 0.13 and 0.39 μmol L−1, respectively for DAC. The pharmacokinetic parameters of VAR alone and in combination with DAC after oral administration to rabbits were successfully estimated. The obtained results confirm that when DAC is co‐administered with VAR, plasma concentration of VAR increases, which necessitates dose adjustment for VAR to prevent toxicological consequences in patients.

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Investigation of anti-Hepatitis C virus, sofosbuvir and daclatasvir, in pure form, human plasma and human urine using micellar monolithic HPLC-UV method and application to pharmacokinetic study

Cited by 16 publications

References 17 publications

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

Validated Stability Indicating HPLC Method for Estimation of Daclatasvir

Pencil Graphite Electrode Decorated with Xylenol Orange Flakes for Studying Possible Pharmacokinetic Interaction Between Vardenafil and Daclatasvir

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