Method Development
and Method Validation of Volatile Leachables Amount for Oncology Drug Product Injection
by Headspace Gas Chromatography Mass Spectrometry Technique
Gorre Vijaya Chandra, Lakshmi Bavisetti and Karunakar Anantam
Res. J. Chem. Environ.; Vol. 29(5); 118-127;
doi: https://doi.org/10.25303/295rjce1180127; (2025)
Abstract
An HS-GC-MS method for the analysis of volatile leachable amounts was develop and
validated. The analytical method used to determine the volatile leachable amount
of toluene in packaging materials for melphalan hydrochloride for injection and
sterile diluent for melphalan for injection by HS-GC-MS method. The validation was
performed on Agilent DB-624 30m×0.25mm×1.4μm chromatographic column and the flow
mode is constant flow with inlet temperature 240℃ and set flow rate is 1.5 mL/min
and the syringe temperature was set at 90℃. Incubation temperature is 80℃, incubation
time is 20 minutes and split ratio is 50:1 and injection volume is 1000μL and carrier
gas was helium.
The validation results of volatile leachables amount of toluene were linear over
the concentration from 0.0101 μg/mL to 1.5156μg/mL (r = 0. 99) and the recoveries
and precision ranged from 86% to 108% (RSD < 10%, n =6). This method has been developed
and validated successfully and all the results met the acceptance criteria. Hence
this method is suitable for testing of volatile leachable amounts of melphalan hydrochloride
for injection and sterile diluent for melphalan for injection.
