Quantification of Sofosbuvir and Velpatasvir in Human Plasma using LCMS/MS Technique -Application to Pharmacokinetic Study

Konam, Kishore; Reddy, Somasekhar

doi:10.5530/jyp.2019.11.54

Cited by 3 publications

(1 citation statement)

References 7 publications

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“…The concentrations of SOF, GS‐331007, and VEL in plasma and dialysate were quantified with a fully validated liquid chromatography mass spectrometry technique (LC–MS/MS) according to previous reports with modifications. 21 , 22 Chromatographic separation was performed with a Luna C18 column (100 × 2 mm, 3 μm, Phenomenex, USA). The column oven was set at 40°C.…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection

Chariyavilaskul,

Prompila,

Wittayalertpanya

et al. 2024

Clinical Translational Sci

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Sofosbuvir/Velpatasvir (SOF/VEL) is a combination drug used for chronic hepatitis C (HCV) infection. However, limited information exists regarding the pharmacokinetics of SOF/VEL and its metabolites in hemodialysis patients. We conducted a prospective investigation of the pharmacokinetic parameters of SOF/VEL after a single dose of SOF/VEL (400/100 mg) on days with and without dialysis in 12 Thai hemodialysis patients with chronic HCV infection, who had been undergoing hemodialysis for a duration of 0.5–20 years. Blood samples were collected before dose (0) and 0.5, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, and 12.0 h after dose. Dialysate samples were also collected before dose (0) and 1.0, 2.0, 3.0, and 4.0 h after dose. Plasma and dialysate samples were quantified for SOF and its metabolite, GS‐331007, and VEL concentrations using a fully validated LCMS technique. In addition, a preliminary efficacy study was conducted using the proposed SOF/VEL dose reduction regimen in all patients. No differences in SOF/VEL PK parameters between on‐ and off‐dialysis studies. On the contrary, GS‐331007 exhibited a 30% reduction in the area under the plasma concentration–time curve from time 0 to 24 h (AUC0‐24h) on dialysis days compared with non‐dialysis days (AUC0‐24h ratio 0.68 vs. 1.04, respectively). The dialysis clearance of SOF and GS‐331007 was 9.35 (8.72–15.11) and 8.89 (8.52–14.07) mL/min, respectively. Subsequently, an alternate‐day regimen of SOF/VEL (400/100 mg) was administered for 12 weeks, resulting in an undetectable plasma HCV viral load without side effects. Further clinical studies are warranted to validate the efficacy and safety of our proposed dose reduction regimen.

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Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection

Chariyavilaskul,

Prompila,

Wittayalertpanya

et al. 2024

Clinical Translational Sci

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Development of Stability Indicating HPLC-UV Method for Determination of Process Impurities and Degradation Products in Sofosbuvir and Velpatasvir Tablets

Zaman

Hassan

2021

Pharm Chem J

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A simple and sensitive stability indicating HPLC-UV method was developed for the analysis of process impurities and degradation products in Sofosbuvir and Velpatasvir pharmaceutical formulations. Analysis was performed on C18 analytical column (250 mm 4.6 mm, 5 m), using a mobile phase of 0.05M ammonium acetate buffer (pH 6.5) with acetonitrile at 45 : 55 (v/v) ratio and a flow rate of 1.0 mL/min. The detection wavelength for simultaneous determination of both ingredients using UV detector was 268 nm. The method was validated for accuracy, precision, linearity, and specificity using reference standards of process impurities and degradation products. The calibration curve was linear and the limits of detection and quantification were determined using 3 /slope and 10 /slope expressions, respectively. Forced degradation studies for Sofosbuvir and Velpatasvir drug substances and products were designed under different environmental stress conditions. The effect of alkaline, acidic, oxidative, and thermal stress conditions on Sofosbuvir and Velpatasvir substances and dosage forms was studied. The influence of heat and humidity was studied at 80 5°C and 75 5% RH. Similarly, the photolytic studies were performed on visible light at 200 W h/m 2 UV and 1.2 million lux h/m 2 in a climatic chamber. The proposed method is stability-indicating and has been successfully applied to the analysis of process impurities and degradation products in Sofosbuvir and Velpatasvir pharmaceutical formulations. The degradation products were characterized by MS, NMR and IR spectroscopy analysis for identification of degradation products and determination of mechanisms.

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Analytical and Bioanalytical Methods for the Quantification of the Nucleotide Polymerase Inhibitor - Sofosbuvir: A Critical Review (2015-2021)

Pathak

Bhardwaj

Godela³

2023

CPA

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Sofosbuvir is a regularly used antiviral medication that was approved for clinical usage in hepatitis C patients. Sofosbuvir belongs to the nucleotide analog drug class, and it operates by inhibiting hepatitis C NS5B protein. This study focuses on the many analytical methods for detecting and quantifying Sofosbuvir in pharmaceutical formulations, biological samples, and fixed dosage combinations. Chromatographic techniques, electro-analytical methods, chemometric procedures, and optical approaches are just a few of the approaches mentioned in the literature. The most often used methods for the analysis of Sofosbuvir are HPLC-based methods with UV/Vis spectrophotometric, fluorescence, and mass spectrometric detection. This article could be extremely useful in the creation of upcoming Sofosbuvir analytical approaches or investigations.

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Quantification of Sofosbuvir and Velpatasvir in Human Plasma using LCMS/MS Technique -Application to Pharmacokinetic Study

Cited by 3 publications

References 7 publications

Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection

Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection

Development of Stability Indicating HPLC-UV Method for Determination of Process Impurities and Degradation Products in Sofosbuvir and Velpatasvir Tablets

Analytical and Bioanalytical Methods for the Quantification of the Nucleotide Polymerase Inhibitor - Sofosbuvir: A Critical Review (2015-2021)

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