A UHPLC–MS/MS method for the quantification of direct antiviral agents simeprevir, daclatasvir, ledipasvir, sofosbuvir/GS-331007, dasabuvir, ombitasvir and paritaprevir, together with ritonavir, in human plasma

Amato, Alessandra; Favata, F.; Nicolò, Amedeo De; Simiele, Marco; Paglietti, Luca; Boglione, Lucio; Cardellino, Chiara Simona; Carcieri, Chiara; Perri, Giovanni Di; D’Avolio, Antonio

doi:10.1016/j.jpba.2016.04.031

Cited by 116 publications

(63 citation statements)

References 13 publications

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“…Some antiviral drugs, including SF and LD, were determined in human plasma by Ariaudo et al using solid phase extraction (SPE) coupled with LC-MS [12]. Although SPE was used, the method lacks the required sensitivity and the LOQ of SF was 11.7 ng/ml.…”

Section: Introductionmentioning

confidence: 99%

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Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Rezk

Bendas

Basalious

et al. 2016

Journal of Chromatography B

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Section: Introductionmentioning

confidence: 99%

“…Although SPE was used, the method lacks the required sensitivity and the LOQ of SF was 11.7 ng/ml. This high LOQ of SF is inadequate to quantify it in bioequivalence studies and in real samples and SF concentration was undetectable in many samples [12].…”

Section: Introductionmentioning

confidence: 99%

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Rezk

Bendas

Basalious

et al. 2016

Journal of Chromatography B

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“…Plasma level measurement of DCV and RBV was performed at the end on dosing interval before the assumption of the new dose (C trough ) at 2 weeks and 1, 2, and 3 months of treatment; the RBV quantification was performed through a previously published high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method [5]; DCV quantification in plasma was performed through a previously published UHPLC-MS/MS method [6] (validated following FDA guidelines) using a Shimadzu NexeraX2 ® system coupled with the LCMS-8050 mass spectrometer (Shimadzu, Milan, Italy).…”

Section: Pk Of DCV and Rbvmentioning

confidence: 99%

Daclatasvir Plasma Levels in a Cohort of Patients with Hepatitis C Virus Infection Taking Methadone: A Prospective Analysis

Boglione¹,

Nicolò²,

Pinna³

et al. 2018

Eur Addict Res

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Backround: The effect of methadone (MET) during therapy with novel direct-acting antiviral agents is still not fully understood. Currently, no data are available about the influence of MET on daclatasvir (DCV) plasma levels in patients affected by chronic hepatitis C (CHC). The aim of this study was to assess the DCV plasma concentrations in patients treated with sofosbuvir (SOF) plus DCV, with or without ribavirin (RBV) and with or without MET. Methods: In this analysis, 47 patients were included, treated consecutively with SOF + DCV ± RBV for 24 weeks, from May to October 2015; 22 (46.8%) received MET substitutive therapy. Results and Conclusion: We found a significant difference in DCV levels at 2 weeks and 1 month: 150 ng/mL in patients without MET and 313 ng/mL with MET at 2 weeks (p < 0.001), 149 and 279 ng/mL at 1 month (p = 0.006). DCV levels were lower in cirrhotic patients (p < 0.001); among cirrhotic patients we also evidenced higher DCV concentrations in patients receiving MET at 2 weeks, 1 and 2 months (p < 0.001, p = 0.005, and p = 0.031, respectively). In multivariate analysis, the only predictive factor associated with DCV plasma levels was the presence of MET. The reason for this increased DCV exposure is unclear; on the clinical side, we have not observed significant adverse events related to the reduction or increase of MET plasma levels. The administration of MET in patients with advanced fibrosis or cirrhosis leads to an early increase of DCV plasma level without significant clinical effects or toxicity.

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“…LDI was quantified alone using high performance liquid chromatography (HPLC) [8]. On the other hand, the studied mixture was quantified using HPLC [9] and LC-MS/MS methods [10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Validated simultaneous spectrophotometric quantification of a new antiviral combination

Abdel-Gawad

2017

Eur. J. Chem.

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Simple, selective and precise spectrophotometric methods were applied for simultaneous quantification of sofosbuvir (SFV) and ledipasvir (LDI) both in their raw and dosage forms. In the first method, the two cited drugs were determined simultaneously using first derivative (D 1 ) method. It was accomplished by measuring peak heights at 275 nm and 344 nm, for SFV and LDI, respectively, in concentration ranges of 5 -80 μg/mL and 3 -50 μg/mL, for SFV and LDI, respectively. In the second one, a first derivative of ratio spectra ( 1 DD) method was adopted to quantify SFV in concentration range of 5 -80 µg/mL. It was adopted by measuring the peak amplitudes (valley and peak) at 259 nm and 280 nm, using 25 µg/mL LDI as a divisor. The proposed method was also used to determine LDI in concentration range of 3 -50 µg/mL by recording the peak amplitudes (valley and peak) at 319 nm and 375 nm, using 80 µg/mL SFV as a divisor. The developed methods were validated with respect to linearity, accuracy, precision, selectivity, robustness and limits of detection and quantification (LOD and LOQ), as per the guidelines of International Conference on Harmonization (ICH)-Q2B.

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A UHPLC–MS/MS method for the quantification of direct antiviral agents simeprevir, daclatasvir, ledipasvir, sofosbuvir/GS-331007, dasabuvir, ombitasvir and paritaprevir, together with ritonavir, in human plasma

Cited by 116 publications

References 13 publications

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Quantification of sofosbuvir and ledipasvir in human plasma by UPLC–MS/MS method: Application to fasting and fed bioequivalence studies

Daclatasvir Plasma Levels in a Cohort of Patients with Hepatitis C Virus Infection Taking Methadone: A Prospective Analysis

Validated simultaneous spectrophotometric quantification of a new antiviral combination

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