Development and Validation for Quantitative Determination of Genotoxic Impurity in Gemfibrozil by Gas Chromatography with Mass Spectrometry

All regulatory organizations are paying close attention to the identification and measurement of genotoxic contaminants. Using conventional analytical techniques like high-performance liquid chromatography (HPLC) gas quantify probable substances (PGIs) at trace level is difficult (GC). Therefore, there a necessity for advanced development highly sensitive procedures determination trace-level PGIs in drug products substances. This study’s goal develop evaluate an technique measuring allyl chloride, possible contaminant gemfibrozil. For detection very low levels impurities, with triple quadrupole mass spectrometry detector (GC-MS/MS) approach was developed validated. column USP phase G27, nonpolar bleed 5% diphenyl, 95% dimethylpolysiloxane, dimensions 30 m length, 0.32 mm internal diameters, 1.5 film thickness, along flow rate 2.0 mL/min Helium (He) as carrier gas, this method uses thermal gradient elution program. The calibrated linearity range from 30% 150% concentration respect specification achieved limit (LOD) quantification (LOQ) were 0.005 ppm 0.01 ppm, respectively, chloride. According current ICH requirements, validated, it discovered be specific, exact, accurate, linear, sensitive, tough, robust, stable. suitable determining chloride regular analysis Gemfibrozil.