Original GC-FID Determination of Non-Chromophoric Impurities in Quetiapine: An Antipsychotic Drug
2010
Jadhav, Sanjay A | Landge, Shashikant B | Shelke, Samadhan S | Niphade, Navanath C | Panchangam, Raghavendra K | Mathad, Vijayavitthal T | Bembalkar, Saroj R
A rapid and sensitive gas chromatographic method using flame ionization detection (GC-FID) has been developed and validated for five process related non-chromophoric impurities viz, 2-(2-chloroethoxy)ethanol (2-CEE), piperazine, 2-(piperazin-1-yl)ethanol (HEP), 2-[2-(piperazin-1-yl)ethoxy]ethanol (HEEP), 2,2-[piperazine-1,4-diylbis(ethane-2,1-diyloxy)]diethanol (DEEP) observed during the process development of quetiapine hemifumarate, an antipsychotic drug is presented. All five non-chromophoric impurities ranging from 0.05 to 0.1% were detected using DB-5 (30 m × 0.53 mm, 5 μm) column with a good peak separation. The method was fully validated according to the ICH Q2 (R1) guidelines. The investigated validation protocols showed that the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity with detection limits and quantitation limits ranging from 0.001 to 0.01% and 0.004 to 0.03%, respectively. These non-chromophoric impurities generated during the process were identified by GC-MS and are characterized by MS, ¹H NMR and FT-IR spectroscopy.
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