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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 12
First page : ( 5637) Last page : ( 5642)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.01022.3

New stability indicating RP-UFLC method for the simultaneous determination of Velpatasvir and Sofosbuvir in tablets

Hemchand S.1,*, Babu R. Ravi Chandra1, Annapurna Mukthinuthalapati Mathrusri2

1GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, India

2GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

*Corresponding Author E-mail: hemchand.suryadevara@gmail.com

Online published on 18 May, 2019.

Abstract

A new liquid chromatographic method has been developed for the simultaneous determination of Sofosbuvir and Velpatasvir in oral dosage forms. Shimadzu Model CBM-20A/20 Alite with C8 (Phenomenex) column (250 mm × 4.6 mm i.d., 5 μm particle size) was used for the chromatographic study. Linearity was observed over the concentration range 4.54–400.14 μg/ml and 1.09–100.36 μg/ml with regression equations y = 26855x + 83874 (correlation coefficient 0.9997) and y = 35840x + 8543.8 (correlation coefficient 0.9999) for Sofosbuvir and Velpatasvir respectively. Sofosbuvir and Velpatasvir were subjected to forced degradation and the method was validated as per ICH guidelines.

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Keywords

Velpatasvir, Sofosbuvir, RP-UFLC, stability-indicating, validation, ICH guidelines.

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