Author(s): Sunkara Namratha, A. Vijayalakshmi

Email(s): nimmi.arun58@gmail.com

DOI: 10.5958/0974-360X.2021.00294.8   

Address: Sunkara Namratha1*, DR. A. Vijayalakshmi2
1Research Scholar, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai - 600117, Tamil Nadu, India.
2School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai - 600117, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 3,     Year - 2021


ABSTRACT:
The aim of technique was to develop simple, accurate, rapid, precise and validated Ultra Performance Liquid Chromatographic (UPLC) method for the coinciding analysis of Sofosbuvir and Velpatasvir in pharmaceutical dosage form. The improvement of the strategy was done and also the chromatograms showed smart resolution, retention time, peak response and lowest noise control line ratio by working 50% 0.01N Potassium phosphate monobasic buffer: 50% Acetonitrile at a wavelength of 260nm employing UV detector. The retention time of Sofosbuvir and Velpatasvir was constitute to be 1.188 min and 0.833 min at a flow rate of 0.3ml/min. The present technique was valid for Percent Assay, accuracy, precision, Linearity, LOD and LOQ. The % assay of Sofosbuvir and Velpatasvir was constitute to be 99.66 and 99.76%. The one-dimensionality shown by the medication at a level vary Sofosbuvir (40-240µg/ml) and Velpatasvir (10-60µg/ml) shows regression co-efficient of 0.999 severally. UPLC technique for coinciding estimation of Sofosbuvir and Velpatasvir in Pharmaceutical was developed and valid as per the ICH guidelines.


Cite this article:
Sunkara Namratha, A. Vijayalakshmi. A Validated Stability Indicating UPLC Method for Simultaneous Determination and Degradation studies of Sofosbuvir and Velpatasvir in Pharmaceutical Dosage Forms. Research J. Pharm. and Tech 2021; 14(3):1658-1662. doi: 10.5958/0974-360X.2021.00294.8

Cite(Electronic):
Sunkara Namratha, A. Vijayalakshmi. A Validated Stability Indicating UPLC Method for Simultaneous Determination and Degradation studies of Sofosbuvir and Velpatasvir in Pharmaceutical Dosage Forms. Research J. Pharm. and Tech 2021; 14(3):1658-1662. doi: 10.5958/0974-360X.2021.00294.8   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-3-83


REFERENCES:
1.    Indian Pharmacopoeia, Indian Pharmacopoeia Commission, Controller of Publication, Government of India, Ministry of health and Family Welfare, Ghaziabad, India, 2 (2010) 1657-1658.
2.    British Pharmacopoeia, The British Pharmacopoeial Commission, the stationary office, UK, London, 1408-1409 2 (2011).
3.    Greig SL. Sofosbuvir and Velpatasvir: A Review in Chronic Hepatitis C, pubmed.gov 2016 Oct;76(16):1567-1578.
4.    Durbhakula Pradhathri* et.al., Method Development and Validation for Simultaneous Estimation of Velpatasvir and Sofosbuvir by Using RP-HPLC in Bulk and Pharmaceutical Dosage Form. Pharma research library.
5.    Gandla. Kumara Swamy* et.al., novel stability indicating RP-HPLC method simultaneous determination of sofosbuvir and velpatasvir in bulk and combined tablet dosage forms, Asian Journal of Research in Biological and Pharmaceutical Sciences. 5(4), 2017, 143-151.
6.    Austin* Ultra performance liquid chromatography-A Review, Journal of analytical Pharmaceutical chemistry 2015, 2(6), 1056.
7.    ICH, Validation of analytical procedures: Text and Methodology. International Conference on Harmonization, IFPMA, Geneva, (1996)
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