B.Prathima, M.Vijey Aanandhi, N.K. Srinivasa Rajagopalachari
Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical sciences, Vels Institute of Science Technology and Advanced studies (VISTAS), Pallavaram, Chennai, Tamilnadu, India.
Analytical method Validation for the determination of Residual solvents Analysis in Trabectedin drug substance by Head space Gas chromatography (HSGC)
Authors
Abstract
The aim of the work is focused on the Validation for the determination of Residual solvents analysis in Trabectedin drug substance by Head space gas chromatography (HSGC).Trabectedin is an oncology class of drug used for the treatment of cancer. In Pharmaceutical industry the analysis of Residual solvents is an important factor to be considered as the toxicity of many of these solvents may cause possible risk to human health. Hence the limits of these residual solvents must be noted and followed by pharmaceutical industries which was set and stated by ICH. The Chromatographic separation was performed using GC with Flame Ionization detector (FID) using Helium as “Carrier Gas” with CP Select -624 ( 60m X0.32mm, 1.8μm film thickness) column and Split ratio 10:1 with N-Methyl-2-pyrrolidone as diluent