GAS CHROMATOGRAPHY METHOD OF CLEANING VALIDATION PROCESS FOR 2-PROPANOL RESIDUE DETERMINATION IN PHARMACEUTICAL MANUFACTURING EQUIPMENT
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2014, Vol 6, Issue 3
Abstract
Cleaning validation is an integral operation of good manufacturing practice in pharmaceutical industry. The aim of this study was to validate simple analytical method for detection of 2-propanol residue in equipment, which is likely contaminated with 2-propanol, usually used in the production area. The gas chromatography with flame ionization detection (GC-FID) method was validated on a GC system using DB-FFAP capillary column at the flow rate of 4.9 mL/min. The calibration curve was linear over concentration range from 2.8µg/mL to 110.7µg/mL with a correlation coefficient equal to 0.99981. The detection limit (LOD) and quantitation limit (LOQ) were 1.1µg/mL and 2.8µg/mL, respectively. The simplicity of gas chromatography method makes it useful for routine analysis of 2-propanol residue and is an alternative to corresponding methods.
Authors and Affiliations
Łukasz Czubak, Alina Krygier, Bożena Tejchman- Małecka
Keywords
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