Identification of the Organic Volatile Impurities in Ezitamibe using GC-HS Technique

Durgababu Rapeti1,*,, Kapavarapu Maruthi Venkata Narayanarao1, Pulipaka Shyamala2 and Rallabhandi Murali Krishna3

1GVK Biosciences Pvt. Ltd., Hyderabad-500076, India

2Department of Physical Chemistry, Andhra University, Visakhapatnam-530003, India

3Department of Physical and Nuclear Chemistry and Department of Chemical Oceanography, Andhra University, Visakhapatnam-530003, India

*Corresponding author: E-mail: durgababu_chem416@yahoo.com

Abstract

Ezetimibe prevents intestinal cholesterol synthesis, which in turn reduces the quantity of cholesterol and thereby helps to reduce heart problems and strokes. In the production of ezetimibe, several organic chemical solvents such as methanol, acetone, isopropyl alcohol, dichloromethane, n-hexane, ethyl acetate, tetrahydrofuran, toluene and dimethyl formamide were used. The measurement of residual solvents is necessary for release checks of all drug substances, based on sound manufacturing processes. The analysis of above mentioned nine solvents in ezetimibe drug was investigated using gas chromatographic method employing detection with flame ionization mode. All analyses were performed using ZB-624 column (30 m length × 0.53 mm identification, 3.0 μm thickness film). The column oven temperature flux was managed to maintain for 11 min at 40 ºC and then continued to upsurge to a temperature close of 240 ºC at a rate of 20 ºC/min and retained for 4 min. The flame ionization detector and injector port were managed at 260 and 200 ºC, respectively. Results after the validation of the gas chromatographic method showed the satisfactory linearity, sensitivity, robustness, accuracy, selectivity and precision for the tested organic solvents. This gas chromatographic approach can therefore be exploited in the assessment of studied nine residual chemical solvents for periodic analysis by gas chromatography for samples of ezetimibe drug.

Keywords

Gas chromatography, Head space, Flame ionization, Ezetimibe, Validation, Residual chemical solvents.

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