Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
Volume 7 | Issue - 1 articles in press
A highly sensitive analytical gas chromatography (GC) method was developed for the simultaneous quantification of trace-level impurities of Chlorobenzene, 1,4-dichlorobenzene, 1,2,4-Trichlorobenzene, and 1-Napthylamine in the drug substance of Sertraline Hydrochloride. These genotoxic impurities have been demonstrated to induce genetic mutation and chromosomal rearrangement and have the potential to cause cancer. The analysis was accomplished on a DB-17 (50%-phenyl)-methylpolysiloxane fused silica) (30-meter x 0.53mm, 1.0μ) GC analytical column using Helium as a carrier gas, flame ionization detector (FID) as a detector with detector temperature of 260°C and injector port temperature of 250°C, injection volume 1.0 μL with split ratio mode and column oven temperature for proper separation with respectable resolution. The method was validated for analytical parameters such as system suitability, specificity, linearity and range, accuracy, limit of detection (LOD), limit of quantification (LOQ), precision, and solution stability. The LOD and LOQ for Chlorobenzene, 1,4-dichlorobenzene, 1,2,4-trichlorobenzene, and 1-Napthylamine were determined to be 1.9 ppm and 6.25 ppm. The method demonstrated specificity in accurately identifying the target impurities, and precision studies confirmed its reproducibility and reliability. The method presents a simple and reliable solution for ensuring the quality and safety of pharmaceutical products containing sertraline hydrochloride.