Simultaneous Estimation of Sofosbuvir and Velpatasvir Tablets by RP- HPLC Method
DOI:
https://doi.org/10.21276/IJRDPL.2278-0238.2018.7(5).3092-3099Keywords:
Sofosbuvir, Velpatasvir, Retention time, Method development, Method ValidationAbstract
ABSTRACT: OBJECTIVES: To develop a simple, accurate, precise method was developed for the simultaneous estimation of the Sofosbuvir and Velpatasvir in tablet dosage form by Reverse Phase-High Performance Liquid Chromatographic Method (RP-HPLC). METHODS: Chromatogram was run through Standard Discovery C18 250 x 4.6 mm, 5?. Mobile phase containing 0.1% Orthophosphoric acid (Buffer with pH 3.2): Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm. RESULTS: Retention time (RT) of Sofosbuvir and Velpatasvir were found to be 2.836 min and 3.678. %Relative Standard deviation (RSD) of the Sofosbuvir and Velpatasvir were found to be 0.4 and 0.2 respectively. %Recovery was obtained as 99.10% and 100.01% for Sofosbuvir and Velpatasvir respectively. Limit of detection (LOD), Limit of quantification (LOQ) values obtained from regression equations of Sofosbuvir and Velpatasvir were 0.10, 0.31 and 0.15, 0.46 respectively. CONCLUSIONS: Retention times were decreased and run time was decreased, hence, the suggested RP-HPLC method can be used for routine analysis of Sofosbuvir and Velpatasvir in Pharmaceutical dosage form.
Downloads
References
Kalpana Nekkala, Shanmukha Kumar JV, Ramachandran D. Analytical Method Development and Validation for the Simultaneous Determination of Sofosbuvir and Velpatasvir drug product by Reverse phase Method. Asian journal of pharmaceutical and clinical research, 2018;11(2):164-168.
P. Mohan Vikas, Dr. T. Satyanarayana, D. Vinod Kumar, E. Mounika, M. Sri Latha, R. Anusha and Y. Sathish. Development and validation of new RP-HPLC method for the determination of sofosbuvir in pure form. 2016; 5(5); 775-781.
Mohamed El-Kassem M Hassouna, Maha Mohammed Abdelrahman and Mahmoud Abdelfatah Mohamed. Assay and dissolution Methods Development and Validation for Simultaneous Determination of Sofosbuvir and Ledipasvir by RP-HPLC Method in Tablet Dosage Forms, Journal of Forensic Sciences & Criminal Investigation 2017; 1;505-9.
Ravikumar Vejendla, C.V.S. Subramanyam, G. Veerabhadram. Estimation and validation of sofosbuvir in bulk and tablet dosage form by RP-HPLC. International Journal of Pharmacy 2016; 6(2): 121-127.
Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Controller of Publication, Government of India, Ministry of health and Family Welfare, Ghaziabad, India 2010; 2: 1657-1658.
David Watson G. Pharmaceutical Analysis. Edinburgh: Churchill Livingstone H Arcourt publishers 2000; 237-252.
ICH Topic Q 2, Validation of Analytical Procedures, Text and Methodology European Medicines Agency, West Ferry Circus, Canary Wharf, London, E14 4HB, UK (v).
ICH, Validation of analytical procedures: Text and Methodology. International Conference on Harmonization, IFPMA, Geneva, (1996).
Steven Walfish. Analytical Methods, A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods. BioPharm International 2006; 1:1-6.
How to cite this article:
Sreehitha V, Sireesha R, Sivagami B, Kumar VP, Chandrasekar R, Babu MN. Simultaneous Estimation of Sofosbuvir and Velpatasvir Tablets by RP- HPLC Method Simultaneous Estimation of Sofosbuvir and Velpatasvir Tablets by RP- HPLC Method. Int. J. Res. Dev. Pharm. L. Sci. 2018; 7(5): 3092-3099. doi: 10.13040/IJRDPL.2278-0238.7(5).3092-3099.
This Journal is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.
.