Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ASSAY OF MEDETOMIDINE

Nuzhath Fathima*, P. Raveendra Reddy, M. Brahmaiah and G. Abdul Huq

ABSTRACT

A simple and rapid RP-HPLC method is developed for the determination and assay of medetomidine. The IUPAC names of medetomidine is (RS)-4-[1-(2, 3-dimethylphenyl) ethyl]-3H-imidazole. Due to high efficiency and suitability for polar moieties an X-terra RP- 18(250X4.6) 5 μm column is selected for chromatographic separation using gradient program. The flow rate of the mobile phase was 1.5 ml/min, column is maintained at 400C and the wavelength detection is 220 nm. The injection volume is 20 μl and the data acquisition time is 14 min. The typical retention time of Medetomidine is 7.53 minutes The developed method is validated in terms of system suitability, specificity, linearity range, precision, accuracy, robustness, limits of detection (LOD) and quantification (LOQ) for medetomidine following the ICH guidelines. The proposed method is therefore suitable for the determination and assay of medetomidine by RP-HPLC method.

Keywords: Medetomidine, Method development and validation, X-terra RP-18, RPHPLC.