Sensitive spectrofluorimetric assay based on micelle enhanced protocol for the determination of hepatitis C antiviral agent (simeprevir): Application to dosage form and human plasma

2020 ◽  
Vol 152 ◽  
pp. 104372 ◽  
Author(s):  
Bassam Shaaban Mohammed ◽  
Amal E. Hamad ◽  
Samah F. El‐Malla ◽  
Sayed M Derayea
Keyword(s):  
Hepatitis C ◽  
Human Plasma ◽  
Dosage Form ◽  
Antiviral Agent

Development and Validation of a New Method for the Determination of Anti-hepatitis C Agent Simeprevir in Human Plasma using HPLC with Fluorescence Detection

2020 ◽  
Vol 16 (4) ◽  
pp. 428-435
Author(s):  
Ahmed F.A. Youssef ◽  
Yousry M. Issa ◽  
Kareem M. Nabil
Keyword(s):  
Hepatitis C ◽  
Human Plasma ◽  
Fluorescence Detection ◽  
Internal Standard ◽  
Protein Precipitation ◽  
Assay Method ◽  
Fluorescence Detector ◽  
Limit Of Quantification ◽  
Relative Standard

Background: Simeprevir is one of the recently discovered drugs for treating hepatitis C which is one of the major diseases across the globe. Objective: The present study involves the development of a new and unique High-Performance Liquid Chromatography (HPLC) method using fluorescence detection for the determination of simeprevir (SIM) in human plasma. Methods: Two methods of extractions were tested, protein precipitation using acetonitrile and liquidliquid extraction. A 25 mM dipotassium hydrogen orthophosphate (pH 7.0)/ACN (50/50; v/v), was used as mobile phase and C18 reversed phase column as the stationary phase. The chromatographic conditions were optimized and the concentration of simeprevir was determined by using the fluorescence detector. Cyclobenzaprine was used as an internal standard. Results: Recovery of the assay method based on protein precipitation was up to 100%. Intra-day and inter-day accuracies range from 92.30 to 107.80%, with Relative Standard Deviation (RSD) range 1.65-8.02%. The present method was successfully applied to a pharmacokinetic study where SIM was administered as a single dose of 150 mg SIM/capsule (Olysio®) to healthy individuals. Conclusion: This method exhibits high sensitivity with a low limit of quantification 10 ng mL-1, good selectivity using fluorescence detection, wide linear application range 10-3000 ng mL-1, good recovery and highly precise and validation results. The developed method can be applied in routine analysis for real samples.

HPTLC-Densitometric Determination of Allopurinol and its Metabolite Oxypurinol in Human Plasma and Allopurinol in Tablet Dosage Form

2018 ◽  
Vol 8 (4) ◽  
pp. 537-551 ◽  
Author(s):  
Jui J. Pandya ◽  
Mallika Sanyal ◽  
Priyanka A. Shah ◽  
Pranav S. Shrivastav
Keyword(s):  
Human Plasma ◽  
Dosage Form ◽  
Tablet Dosage

scholarly journals Stress stability study of simeprevir, a hepatitis C virus inhibitor, using feasible TLC-spectro-densitometry: application to pharmaceutical dosage form and human plasma

RSC Advances ◽  
2020 ◽  
Vol 10 (36) ◽  
pp. 21100-21107 ◽  
Author(s):  
Bassam Shaaban Mohammed ◽  
Amal E. Hamad ◽  
Sayed M. Derayea
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Human Plasma ◽  
Dosage Form ◽  
Direct Action ◽  
Stability Study ◽  
Pharmaceutical Dosage Form ◽  
Virus Inhibitor

Simeprevir is one of the newest direct action anti-hepatitis C drugs.

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