Reversed-Phase Liquid Chromatographic Method for Determination of Daclatasvir Dihydrochloride and Study of Its Degradation Behavior

Hassib, Sonia T.; Taha, Elham A.; Elkady, Ehab F.; Barakat, Ghada H.

doi:10.1007/s10337-017-3321-3

Cited by 21 publications

(8 citation statements)

References 8 publications

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“…[ 4,5,7 ] In addition, daclatasvir dihydrochloride has been determined using chromatographic techniques combined with different detection patterns. [ 12–16 ] Generally, chromatographic methodologies require a large volume of hazardous organic solvents, tedious procedures, long time periods, and expensive detectors. Merbromin or sodium mercurescein is a stable low‐cost fluorescent reagent [ 17 ] and has been applied spectrophotometrically and fluorometrically for the quantification of some antibiotics, fluoroquinolones, thio‐compounds, dapoxetine hydrochloride, and allopurinol in their pharmaceutical dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Applying different spectroscopic techniques for the selective determination of daclatasvir using merbromin as a probe: Applications on pharmaceutical analysis

Almahri

Abdel‐Lateef

2021

Luminescence

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In this study, rapid resonance Rayleigh scattering (RRS), spectrophotometric, and spectrofluorimetric methods were performed for facile quantitation of daclatasvir dihydrochloride without interference from sofosbuvir (a co‐formulated anti‐hepatitis C virus drug). The proposed approaches were based on forming a binary complex between daclatasvir dihydrochloride and merbromin reagent at pH 4.1. The binary complex was measured spectrophotometrically at λmax = 544 nm. The spectrofluorimetric approach relied on the quenching effect of daclatasvir dihydrochloride on the fluorescence strength of merbromin at λEmission = 545 nm. The RRS approach depended on augmentation in the merbromin RRS spectrum at 363 nm upon addition of daclatasvir dihydrochloride. The presented methodologies were linear over the concentration ranges 2.5−15.0, 0.2−1.6 and 0.15−3.0 μg ml−1 with detection limits of 0.45, 0.046, and 0.036 μg ml−1 for the spectrophotometric approach, the spectrofluorometric approach, and RRS approach, respectively. Current approaches were validated in compliance with International Council for Harmonisation guidelines and utilized practically to estimate daclatasvir dihydrochloride either in binary mixtures with sofosbuvir or in its commercial tablet dosage form with good results. Moreover, the test for content uniformity was applied successfully on commercial tablets using the current spectroscopic approaches.

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Section: Introductionmentioning

confidence: 99%

Applying different spectroscopic techniques for the selective determination of daclatasvir using merbromin as a probe: Applications on pharmaceutical analysis

Almahri

Abdel‐Lateef

2021

Luminescence

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“…Exposure of the SOF metabolite (GS‐331007) was similar in the presence and absence of DAC, while SOF exposures were ~35% higher in the presence of DAC (http://www.hcvdruginfo.ca/downloads/Hepatitis%20Cint_new%20NS5A%20inhibitors.pdf). The published methods for determination of SOF and/or DAC in human plasma are HPLC (Baker, El‐Kafrawy, Mahrous, & Belal, ; Hassib, Taha, Elkady, & Barakat, ; Nannetti et al, ; Srinivasu, Kumar, & Thirupathi, ), LC‐MS/MS (Abdallah, Abdel‐Megied, & Gouda, ; Ariaudo et al, ; Jiang et al, ; Nebsen & Elzanfaly, ; Qu, Wang, Zeng, Lub, & Yin, ; Rezk et al, , , b; Shi et al, ) and electrochemical detection (Azab & Fekry, ). To author's knowledge, this bio‐analytical method is the only LC‐MS/MS method for determination of SOF and DAC in human plasma with application to a pharmacokinetic study for both.…”

Section: Introductionmentioning

confidence: 99%

“…However, NS5A has no known enzymatic functions and so it is difficult to understand its mode of action (Belema et al, 2014;Smith, Regal, & Mohammad, 2016; Figure 1). There are eight metabolites of DAC, one of which (BMS-805215) has some activity; however, it is 100-fold less potent than the parent drug (Product monograph, 2016 (Baker, El-Kafrawy, Mahrous, & Belal, 2017;Hassib, Taha, Elkady, & Barakat, 2017;Nannetti et al, 2017;Srinivasu, Kumar, & Thirupathi, 2016), LC-MS/MS (Abdallah, Abdel-Megied, & Gouda, 2017;Ariaudo et al, 2016;Jiang et al, 2015;Nebsen & Elzanfaly, 2016;Qu, Wang, Zeng, Lub, & Yin, 2015;Rezk et al, 2015Shi et al, 2015) and electrochemical detection (Azab & Fekry, 2017…”

Section: Introductionmentioning

confidence: 99%

Development and validation of LC‐MS/MS method for simultaneous determination of sofosbuvir and daclatasvir in human Plasma: Application to pharmacokinetic study

Abdallah

Abdel‐Megied

Gouda³

2018

Biomedical Chromatography

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A simple and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method was developed and fully validated for the first time for the simultaneous determination of newly discovered antiviral drugs, namely sofosbuvir (SOF) and daclatasvir (DAC) in human plasma. Tadalafil (TAD) was used as internal standard (IS). SOF, DAC and TAD (IS) were extracted from plasma using liquid-liquid extraction technique with methyl tert-butyl ether. The chromatographic separation was carried out using ZorbaxSB-C column (4.6 × 50 mm,5 μm) and 5 mm ammonium formate buffer (pH 3.5)-acetonitrile (50:50, v/v) as mobile phase in an isocratic elution mode pumped at a flow rate 0.7 mL min . The quantitation was performed on API4500 triple quadrupole tandem mass spectrometer with positive electrospray ionization interface in multiple reaction monitoring mode. Validation was applied according to US Food and Drug Administration guidelines for bio-analytical methodswith respect to linearity, precision, accuracy, selectivity, carry-over, stability and dilution integrity. Linearity was obtained over concentration ranges of 0.3-3000 and 3-3000 ng mL for SOF and DAC, respectively, by applying a weighted least-squares linear regression method (1/x ). The proposed method could be applied successfully in bioequivalence and/or clinical studies for therapeutic drug monitoring of patients undergoing dual combination therapy as the latter combination proved more efficacious and powerful tool for the complete treatment of hepatitis C genotype 3 within 16 weeks. The suggested method has been applied successfully to pharmacokinetic studies with excellent assay ruggedness and reproducibility.

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“…Literatures review reveals several LC methods for determination of daclatasvir , sofosbuvir together with its metabolite , simultaneous determination of LDS and SFS and SMP alone . A spectrophotmetric method was found for simultaneous determination of DAC and SFS .…”

Section: Introductionmentioning

confidence: 99%

Comparison between core–shell and totally porous particle stationary phases for fast and green LC determination of five hepatitis‐C antiviral drugs

Ibrahim¹,

Hashem

Elhenawee

et al. 2018

J of Separation Science

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The performances of core-shell 2.7 μm and fully porous sub-2 μm particles packed in narrow diameter columns were compared under the same chromatographic conditions. The stationary phases were compared for fast separation and determination of five new antiviral drugs; daclatasvir, sofosbuvir, velpatasvir, simeprevir, and ledipasvir. The gradient elution was done using ethanol as green organic modifier, which is more environmentally friendly. Although both columns provided very good resolution of the five drugs, core-shell particles had proven to be of better efficiency. Under gradient elution conditions, core-shell particles exhibited faster elution, better peak shape, and enhanced resolution adding to lower system backpressure. The column backpressure on sub-2 μm particles was more than twice that on core-shell particles. This gives a chance to use conventional high-performance liquid chromatography conditions without needing special instrumentation as that required for ultra-high performance liquid chromatography. The method was validated for determination of the five drugs by gradient elution using mobile phase composed of organic modifier ethanol and aqueous part containing 0.75 g sodium octane sufonate and 3.0 g sodium dihydrogen phosphate per liter at pH of 6.15. Detection was done using UV-detector set at 210 nm. The linearity, accuracy, and precision were found very good within the concentration range of 2-200 μg/mL.

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Reversed-Phase Liquid Chromatographic Method for Determination of Daclatasvir Dihydrochloride and Study of Its Degradation Behavior

Cited by 21 publications

References 8 publications

Applying different spectroscopic techniques for the selective determination of daclatasvir using merbromin as a probe: Applications on pharmaceutical analysis

Applying different spectroscopic techniques for the selective determination of daclatasvir using merbromin as a probe: Applications on pharmaceutical analysis

Development and validation of LC‐MS/MS method for simultaneous determination of sofosbuvir and daclatasvir in human Plasma: Application to pharmacokinetic study

Comparison between core–shell and totally porous particle stationary phases for fast and green LC determination of five hepatitis‐C antiviral drugs

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