Abstract

Estimation of residual solvents for any drug substances before its marketing is a must requirement imposed by most of the regulatory bodies across the globe. Choice of analytical instrument (SHS-GC) remains same. A generic method was developed for the quantification of 38 residual solvents by SHS-GC, the response factors for the solvents were determined. Effect of chromatographic condition injection port temperature, carrier gas flow, detector temperature, incubation temperature of head space, incubation time and effect of matrix on the recoveries of the solvents was studied. Undertaken studies will be useful the researchers for the development of method for the estimation of residual solvents.

Keywords

Residual solvents, HS-GC, ICH, Pharmacopoeia

Cite This Article

Kathiriya, P.P., Khunt, R.C. (2016). Strategies for Head Space Gas Chromatographic Analysis of Residual Solvents, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(4), 80-87.