METHOD DEVELOPMENT AND VALIDATION OF UV- VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF SOFOSBUVIR AND LEDIPASVIR IN PHARMACEUTICAL API AND ITS FORMULATION
| Main Author: | N. Mohana Vamsi 1 *, Dr. Y. Padmanabha Reddy 2, Dr. R. Vijay Kumar 3 |
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| Format: | Article |
| Terbitan: |
, 2018
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| Subjects: | |
| Online Access: |
https://zenodo.org/record/1286319 |
Daftar Isi:
- ABSTRACT Objective: The objective of the present work is to develop a simple, efficient, and reproducible spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Sofosbuvir and Ledipasvir in its active pharmaceutical ingredient (API) form and its formulation. Methods: The developed ultraviolet spectrophotometric method for the quantitative estimation of hepatitis-C drugs - Sofosbuvir and Ledipasvir is based on measurement of absorption at a wavelength maximum (λmax) of 260 and 338 nm using water and acetonitrile as solvent. Results: The method was validated in terms of specificity, precision, linearity, accuracy, and LOD & LOQ as per the ICH guidelines. The method was found to be linear in the range of 25-150% for Sofosbuvir and Ledipasvir. Relative standard deviation for precision results were found to be <2%.The correlation coefficient value observed for Sofosbuvir and Ledipasvir drug substances was more than >0.99, Results obtained from the validation experiments prove that the developed method is quantified for the estimation of Sofosbuvir and Ledipasvir drug substances. Conclusion: The developed method can be successfully applied for routine analysis, quality control analysis, and also suitable for stability analysis of Sofosbuvir and Ledipasvir in API form and its formulation as per the regulatory requirements. KEYWORDS: Sofosbuvir, Ledipasvir, Method development, Validation, Ultraviolet-visible Spectrophotometry.