SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF SOFOSBUVIR AND DACLATASVIR IN PURE AND DOSAGE FORMS

MONIR Z. SAAD; ATEF AMER; KHALED ELGENDY; BASEM ELGENDY

doi:10.22159/ijap.2021v13i6.42564

Authors

MONIR Z. SAAD Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
ATEF AMER Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
KHALED ELGENDY Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt
BASEM ELGENDY Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt

DOI:

https://doi.org/10.22159/ijap.2021v13i6.42564

Keywords:

Sofosbuvir, Daclatasvir, Spectrophotometry, Cerium (IV), Dyes, Method validation, Dosage forms

Abstract

Objective: Two simple, sensitive and accurate spectrophotometric methods have been developed for the determination of sofosbuvir (SOF) and daclatasvir (DAC) in pure forms and pharmaceutical formulations.

Methods: The proposed methods are based on the oxidation of SOF and DAC by a known excess of cerium(IV) ammonium nitrate in sulphuric acid medium followed by determination of unreacted cerium(IV) by adding a fixed amount of indigo carmine (IC) and alizarin red S (ARS) dyes followed by measuring the absorbance at 610 and 360 nm, respectively. The experimental conditions affecting the reaction were studied and optimized.

Results: The beer’s law was obeyed in the concentration ranges of 0.2-3.0, 0.2-4.0 for SOF and 0.5-4.5 and 0.5-5.0 μg/ml for DAC using IC and ARS methods, respectively with a correlation coefficient ≥ 0.9991. The calculated molar absorptivity values are 2.354 × 10⁴, 1.933 × 10⁴ for SOF and 1.786 × 10⁴ and 2.015 × 10⁴ L/mol. cm for DAC using IC and ARS methods, respectively u. The limits of detection and quantification are also reported. Intra-day and inter-day precision and accuracy of the methods have been evaluated.

Conclusion: The methods were successfully applied to the assay of SOF and DAC in tablets and the results were statistically compared with those of the reference method by applying Student’s t-test and F-test. No interference was observed from the common tablet excipients. The accuracy and reliability of the methods were further ascertained by performing recovery studies using the standard addition method.

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