Abstract
DETERMINATION OF GENOTOXIC IMPURITY 2,3-DIMETHYLANILINE IN PARACETAMOL AND MEFENAMIC ACID GFOS USING RP-LC

Venkateswara Reddy Billa*, Prof. Anuradha Vejendla and Prof. Ramachandran Dittakavi

ABSTRACT

Highly sensitive method for the determination of genotoxic impurity such as 2,3-Dimethylaniline in Paracetamol and Mefenamic acid GFOS using RP-LC has been presented in the present paper. Quantification of 2,3- Dimethylaniline content in Paracetamol and Mefenamic acid GFOS samples by HPLC with UV Detector. 2,3- Dimethylaniline was determined by RP-LC method using Inertsil ODS-3V (250X4.6mm, 5μm) column as stationary phase. Mobile phase consisted of pH 6.50 phosphate buffer is used as Mobile phase-A and Methanol and water in the ratio of 90:10 v/v used as Mobile Phase-B, with the help of the gradient elution. Column temperature maintained 40°C, Injection volume 25μL, Flow rare was 1.0 ml/min and the separated 2,3- Dimethylaniline was detected using UV detector at the wavelength of 230 nm, sample cooler temperature 25°C and run time was 40mintues. The method validation has been carried as per International Conference on Harmonization guidelines (ICH). Limit of quantitation (LOQ) was found 0.08ppm for 2,3-Dimethylaniline.

Keywords: Genotoxic impurity, Paracetamol and Mefenamic acid GFOS, RP-LC method, validation and limit of quantitation.


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