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DETERMINATION OF GENOTOXIC IMPURITY METHYL PARATOLUENE SULFONATE IN LEVOCETIRIZINE DRUG SUBSTANCE BY USING RP-LC METHOD

. Syed Mastan Ali, Ponnuri Bharath, Syed Khasim Sharif, Dr.V.Siva Ramakrishna and Dr.D.Ramachandran


Abstract

Highly sensitive method for the determination of genotoxic impurity such as methyl para toluene sulfonate (MPTS) in Levocetirizine drug substance using RP-LC has been presented in the present paper. MPTS were determined by RP-LC method using waters symmetry C18 (250 x 4.6mm), 5µ column as stationary phase. Column temperature maintained 30°C, Injection volume 10µL, flow rare was 1.0 ml/min, sample cooler temperature 5°C and run time was 35mintues. pH 2.50 phosphate buffer was used as mobile phase-A and acetonitrile and water in the ratio of 90:10 %v/v was used as mobile phase-B. The method validation has been carried as per International Conference on Harmonization guidelines (ICH). Limit of quantitation (LOQ) was found 64.446 μg/ mL for MPTS.

Key words: Genotoxic impurity, Levocetirizine, RP-LC method, validation and limit of quantitation.

Abbreviations:

LCZ= Levocetirizine , MPTS=Methyl para toluene sulfonate

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