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- Title
Three Smart and Original Spectrophotometric Data Processing Ratio Techniques for Resolving the Partial Overlapped Spectra of the Binary Antiviral Mixture Daclatasvir/Sofosbuvir: Application to Combined Dosage Form DarvoniV® Tablets.
- Authors
Fayed, Ahmed S.; Hegazy, Maha A.; Kamel, Ebraam B.; Eissa, Maya S.
- Abstract
Background: The combination of daclatasvir (DCV) and sofosbuvir (SFV) is now widely used as an ideal treatment for hepatitis C virus (HCV) infection. For this purpose, simple, sensitive, rapid, and smart spectrophotometric methods were developed and validated for the determination of these drugs in their combined dosage form. Objective: Development of smart, sensitive, low-cost spectrophotometric methods for the determination of DCV and SFV in their combined dosage form. Methods: Ratio subtraction (RS), amplitude modulation (AM), and mean-centering spectrophotometric methods were established and validated for the estimation of SFV in the presence of DCV without previous separation, using a unified regression equation. Results: A linearity range of 2.5-25.0 mg/mL was confirmed for the direct measurement of DCV at 316nm (because there is no interference from SFV. Linearity was confirmed over a concentration range of 10.0-80.0 mg/mL for SFV. The current methods were established according to the ICH recommendations, and specificity was examined by testing synthetic mixtures of both drugs. They were tested on their tablet dosage form, and a good recovery was obtained. Conclusion: The current methods proved to be simple, specific, and economical. A statistical study of the current ratio approaches and published methods showed there was no apparent statistical variation. Highlights: Both antiviral agents can be quantified in the presence of each other by the current methods, which is a significant time- and cost-saving benefit of the developed methods. This benefit is even more important in the case of the combined dosage form (DarvoniVR tablets) for the pharmaceutical market.
- Subjects
DOSAGE forms of drugs; BINARY mixtures; ELECTRONIC data processing; SOFOSBUVIR; HEPATITIS C virus; DRUG dosage
- Publication
Journal of AOAC International, 2022, Vol 105, Issue 2, p612
- ISSN
1060-3271
- Publication type
Article
- DOI
10.1093/jaoacint/qsab134