Research paper description Dr. MCD May  2021
                     Research paper of Dr. Mrinalini C. Damle for the month of May 2021
Title:  Stability indicating HPTLC method for Sofosbuvir and Velpatasvir in combination.
Authors: Mrinalini C. Damle, Pooja B. Kalaskar
Journal Details: International Journal of Pharmaceutical Sciences and Drug Research, (2020), 
12(2), 129-135.
Publisher:  MRI Publication Pvt. Ltd.
Description: This research article is about analytical method development and validation for
estimation  of  drug  combination  used  for  the  treatment  of  Hepatitis  C.  This  combination  is
claimed to have an advantage of being highly potent, well tolerated and used once a day. The
analytical method is based on use of HPTLC (High Performance Thin Layer Chromatography).
The  stress  degradation  studies  of  Sofosbuvir  and  Velpatasvir  were  carried  out  under  the
conditions of hydrolysis at various pH, photolysis, thermal and oxidative degradation. Both these
APIs were found to be sensitive to stress degradation conditions. The peak purity was monitored
to ensure “stability indicating” nature of the developed method. The method was validated as per
ICH Q2 (R1) guidelines. 
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