1. Micellar high performance liquid chromatographic method for separation and validation of two anti-hepatitis C- virus drugs in pure form, human plasma and human urine.
- Author
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Hassan WS, Elmasry MS, Shalaby A, El-Sayed HM, and Zidan DW
- Subjects
- Antiviral Agents blood, Antiviral Agents urine, Chromatography, High Pressure Liquid methods, Cost-Benefit Analysis, Humans, Limit of Detection, Reproducibility of Results, Ribavirin analysis, Ribavirin blood, Ribavirin urine, Sofosbuvir analysis, Sofosbuvir blood, Sofosbuvir urine, Solubility, Antiviral Agents analysis, Hepatitis C drug therapy
- Abstract
Objectives: In the present study, an eco- friendly micellar liquid chromatographic technique was validated for separation and quantification of two drugs; namely ribavirin (RIV), and sofosbuvir (SBV) in pure form, pharmaceuticals containing them, human plasma and human urine. These drugs are administered co-administered for treatment of Hepatitis C virus (HCV) that causes hepatitis C in humans., Material and Methods: These drugs were separated using Nucleosil 100-5 phenyl column. Sodium dodecyl sulphate (SDS) solution (0.05M, pH 7.0) containing triethylamine (0.3%) and n-butanol (10%) was used as a mobile phase with 1.2 mLmin
-1 flow rate and 215nm detection wavelength. Nine minutes were required for resolving the two drugs from the matrix., Results: The method showed good linearity for RIV and SBV with correlation coefficients (r2 ) more than 0.9996 within the concentration ranges of (20-400) and (40-400) ngmL-1 in pure form, (30-300) and (50-300) ngmL-1 in human plasma and (20-400) and (40-400) ngmL-1 in human urine, respectively., Conclusion: The recommended method was applied for examination of RIV and SBV in pure and pharmaceuticals. The obtained results were statistically matched with reported methods with no significant differences. Also, the recommended method was effectively applied for estimation of both drugs in spiked human urine and plasma without purification or extraction steps and real samples of plasma and urine of humans having therapy of RIV and SBV, as well as, performing tablets dissolution-rate tests with satisfactory results., (Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)- Published
- 2020
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