Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF LEVEDROPROPIZINE AND CHLORPHENIRAMINE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Jayant S. Bidkar*, Tanuja K. Suroshe, Shital J. Bidkar and Ganesh Y. Dama

ABSTRACT

A new specific, simple, RP-HPLC method was developed for Levodropropizine and Chlorpheniramine in bulk and Syrup formulation. Chromatographic separation was achieved better on Kromosil C18 (4.6 x250mm, particle size 5um) column with mobile phase consist of 0.01N Potassium dihydrogen phosphate Acetonitrile (50:50 v/v) at flow rate 0.8ml/min with maximum absorbance detected at 252 nm using UV-detector. The retention time was found to be 2.233 and 2.949 min respectively. The method was validated for accuracy, precision, linearity, LOD, LOQ, robustness. The method was found to be linear in range of 15-10μg/ml, 1-6 μg/ml with correlation coefficient (r2)0.999 and (r2)0.999 the precision was estimated by interday and intra-day precision and result were calculated as % RSD with found to be within limit. The recovery of Levodropropizine and Chlorpheniramine was found to be 100.06% and 100.63% respevtively. The LOD and LOQ of the method for Levodropropizine and Chlorpheniramine were found to be 0.19μg/ml and 0.02 μg/ml. and 0.56 μg/ml and 0.06 μg/ml the results of the analysis have been validated statistically and by recovery studies. The proposed method validated using standard ICH guideline.

Keywords: RP-HPLC, Levodropropizine, Chlorpheniramine, validation method development, 0.01N Potassium dihydrogen phosphate, Acetonitrile.