Publications by authors named "Kanyawar Nitesh"
J Chromatogr Sci
May 2018
Article Synopsis
- A new high-performance liquid chromatography (HPLC) method was developed to accurately quantify impurities in Ledipasvir, a key pharmaceutical ingredient, using a C18 column and a specific mobile phase for effective separation.
- The method was validated per International Council for Harmonisation guidelines, showing high correlation coefficients over 0.999 and limits of detection/quantification of 0.01% and 0.03% for impurities, with consistent recovery rates of 95-105%.
- Stress testing indicated that significant degradation occurred under photolytic conditions, resulting in the discovery of a new impurity, which was identified using advanced analytical techniques like FT-IR, 1H NMR, and LC-MS/MS.
