Ultrasensitive spectrofluorimetric method for rapid determination of daclatasvir and ledipasvir in human plasma and pharmaceutical formulations.
TL;DR: A novel, fast, simple, ultrasensitive and cost‐effective spectrofluorimetric method designed for determination of DCS and LDS in miscellaneous matrices was designed and validated in compliance with ICH guidelines and US‐FDA guidelines.
About: This article is published in Journal of Pharmaceutical and Biomedical Analysis.The article was published on 2018-04-15. It has received 33 citations till now. The article focuses on the topics: Ledipasvir & Daclatasvir.
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TL;DR: In this article, the first molecularly imprinted polymer-based electrochemical sensor for the determination of the anti-HCV drug, daclatasvir dihydrochloride (DCT), was presented.
Abstract: The recent discovery of the novel viral RNA‒dependent RNA polymerases for treatment of HCV opened the doors for the development of a large number of anti−HCV drugs which require a concurrent development of sensitive analytical methods for their quality‒control and analysis. In this work, we report the first molecularly imprinted polymer‒based electrochemical sensor for the determination of the anti−HCV drug, daclatasvir dihydrochloride (DCT). Since liver patients require continuous medical follow up during the period of their treatment, it is very necessary to develop a simple and fast method for monitoring the DCT concentration in the patient’s biological fluids. In addition, quality control laboratories are in an urgent need for various rapid analytical methods for such a novel drug. The sensor is based on the modification of the traditional carbon‒paste sensor with molecularly imprinted methacrylic acid, cross linked with ethylene glycol dimethacrylate, as a selective adsorbent for DCT, and reduced graphene oxide (RGO) as a sensitizer. The Hartree‒Fock method of calculation was used to optimize the template/functional monomer ratios so as to avoid trial‒and‒error experimental synthesis procedures and to give information about the binding of the template to the functional monomer. The sensor was fully characterized with the aid of cyclic voltammetry, FTIR analysis and scanning electron microscopy (SEM). After optimization of the analytical parameters, the sensor was found to work efficiently at pH 2.5 (Britton Robinson buffer) and a scan rate of 500 mV/s. The sensor showed a good linearity over the concentration range of 40.6 pg/mL to 812 μg/mL with a correlation coefficient of 0.9881. The detection and quantification limits were found to be 12.2 and 40.2 pg/mL, respectively. The proposed sensor was applied for the determination of DCT in bulk solution, pharmaceutical formulation and human urine and plasma samples and excellent recovery values ranging from 99.48 to 103.70% were obtained indicating the accuracy of the proposed sensor.
31 citations
TL;DR: A novel, simple and sensitive electrochemical method for the determination of ledipasvir (LED), the newly FDA approved Hepatitis C antiviral drug was developed and validated using ε-MnO2-modified graphite electrode that exhibits good precision, selectivity and stability.
24 citations
TL;DR: In vitro and in vivo application of the proposed HPTLC method was applied to simultaneous quantitation of sofosbuvir and daclatasvir in real hepatitis C patients' plasma with good percentage recovery.
23 citations
TL;DR: The proposed method was expanded to examine the stability of DAC by determination the parent drug of DAC in the presence of its oxidative, alkaline, acidic, UV, daylight and sunlight degradations products in agreement with ICH guidelines.
22 citations
TL;DR: In this article, the boron-doped diamond electrode pretreated electrochemically (anodic and subsequent cathodic) in the voltammetric determination of hepatitis C antiviral drug ledipasvir was used.
19 citations
References
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TL;DR: In this paper, the fundamental principles of analytical chemistry are discussed, together with a review of the applications of these concepts in analytical chemistry.http://www.documentaries.org.au.
Abstract: Fundamentals of analytical chemistry , Fundamentals of analytical chemistry , کتابخانه دیجیتال جندی شاپور اهواز
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TL;DR: The aim of this review was to summarize the results obtained from recent DAA combination studies without IFN, making HCV, the first chronic viral infection to be eradicated worldwide with a finite duration of combination DAA therapy withoutIFN or ribavirin.
Abstract: For HCV infection, there have been major advancements during last several years with large numbers of ongoing trials with various direct-acting antivirals (DAA) showing high potency, favourable tolerability profile, higher barrier to resistance, shortened treatment duration, all oral regimen, pan-genotypic, fewer drug interactions and reduced pill burden. By 2014, several DAAs are anticipated to complete successful phase III trials and will be commercially available. Initially, a wave of IFN-based regimen (sofosbuvir, faldaprevir and simeprevir) will be available for treatment of HCV genotype 1. In the near future, combination of antiviral agents with additive potency that lack cross-resistance with good safety profile will likely be the new recommended regimens, making HCV, the first chronic viral infection to be eradicated worldwide with a finite duration of combination DAA therapy without IFN or ribavirin. The aim of this review was to summarize the results obtained from recent DAA combination studies without IFN.
226 citations
"Ultrasensitive spectrofluorimetric ..." refers background in this paper
...In addition, all DAA are orally administered [5]....
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...tolerability profile, higher barrier to resistance, pangenotypic coverage, fewer drug interactions, shortened treatment duration and reduced pill burden [5]....
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220 citations
TL;DR: A mechanistic description of NS3/4A protease inhibitors, nucleotide and non-nucleotide inhibitors of the NS5B viral polymerase and inhibitors ofThe NS5A protein is provided, followed by a summary of clinical data from studies of each drug class alone and in combination.
Abstract: The treatment of HCV infection has evolved at an extremely rapid pace over the past few years. The development of direct-acting antiviral agents, which potently inhibit different stages in the viral life cycle, has led to the replacement of interferon with well-tolerated oral therapies with cure rates of >90% in most patient populations. Understanding the mechanisms of action of the various agents as well as related issues, including the molecular basis for resistance, helps to guide drug development and clinical use. In this Review, we provide a mechanistic description of NS3/4A protease inhibitors, nucleotide and non-nucleotide inhibitors of the NS5B viral polymerase and inhibitors of the NS5A protein, followed by a summary of clinical data from studies of each drug class alone and in combination. Remaining challenges in drug development efforts are also discussed.
157 citations
"Ultrasensitive spectrofluorimetric ..." refers background in this paper
...Direct-acting antivirals (DAAs) represent the beginning of the ew era of hepatitis C virus (HCV) treatment [1]....
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TL;DR: This work provides a comprehensive overview of FDA‐approved therapies and newly discovered anti‐HCV agents with a special focus on drug efficacy, mechanisms of action, and safety, and shows that HCV drug development has advanced in multiple aspects.
124 citations
"Ultrasensitive spectrofluorimetric ..." refers background or methods in this paper
...Among these novel DAAs, are daclatasvir (DCS) and ledipasvir (LDS)....
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...Under the optimum conditions, the linear ranges of calibration curves were 0.2-30 and 6-120 ng mL-1 for DCS and LDS, respectively with correlation coefficients ≥0.9998....
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...DCS and LDS were co administered with other drugs such as sofosbuvir (SOF) and/or ribavirin (RBV) [6]....
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...Among these novel DAAs, are daclatasvir (DCS) and ledipasvir (LDS) [6]....
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...Herein, a novel, fast, simple, ultrasensitive and cost-effective spectrofluorimetric method was designed for determination of DCS and LDS in miscellaneous matrices....
[...]