STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF ISOPROTERENOL HCL IN BULK AND ITS FORMULATION BY RP-HPLC USING PDA DETECTION

Abstract

Author(s): S. Muneer*, Hindustan Abdul Ahad, Chandrasekhar Kothapalli Bonnoth

The objective of the present study was to develop an accurate, precise stability indicating reverse phase liquid chromatographic method to quantify Isoproterenol HCl in bulk and its formulation using PDA detection. The chromatographic separation of the analyte from the degradants was achieved on Phenomenex Luna column with mobile phase composition of Methanol and 0.1% Triethyl amine [pH 7.0], [20:80% v/v] at flow rate of 1.0 ml/min. The analyte separation was monitored using PDA detection at 279nm. The method was linear in the concentration range of 10-60 μg/ml. The method shown acceptable percent relative deviations for the Inter-day (0.58%) and Intra-day (0.65%) precisions. The mean percent recovery for accuracy study was within the limit. From the stability studies method has proven specificity to quantify Isoproterenol HCl in presence of its degradation products. The method shown acceptance as according to ICH guidelines