Abstract

METHOD DEVELOPMENT AND VALIDATION OF ITOPRIDE USING UV SPECTROSCOPIC METHOD IN BULK DRUG AND MARKETED FORMULATION

Kumar Raja Jayavarapu*, K. Pavithro, P. Sowjanya, D. Bhavani, M. Dharani and Dr. T. satyanarayana

ABSTRACT

Itopride Hydrochloride is a prokinetic D2 receptor antagonist used for the treatment of functional dyspepsia and other gastrointestinal conditions and to relieve symptoms of heart burn gastroporosis. This paper describes a simple, accurate, specific and validated method for the estimation of Itopride Hydrochloride in pure and in tablet dosage form. A study was carried out of all the parameters established as per ICH guidelines to validate an analytical method for estimation. The method showed high sensitivity with reproducibility in results. The wavelength maxima (λmax) was found to be 258 nm. The linearity for this method was found to be in the range of 5 – 100μg/ml. The calibration curve (Fig -2) was drawn by plotting graph between absorbance and concentration. This method showed a correlation coefficient of 0.9995. The regression equation of the curve wasY= 0.03371x+0.03092. Method was successfully validated. In addition, this proposed method was simple, sensitive, easy to apply and requires relatively inexpensive instruments. The proposed method can be used for routine analysis of Itopride Hydrochloride in bulk as well as in the commercial formulations.

Keywords: Itopride Hydrochloride, UV Spectroscopy, Tablet dosage form, Statistical validation, ICH Guidelines.