A Validated Stability Indicating LC Method for Amlexanox in Bulk Drugs

摘要

A novel and sensitive stability indicating RP-HPLC method has been developed for the quantitative determination of amlexanox in bulk drugs. The separation was accomplished on C18 column using 10 mM ammonium dihydrogen orthophosphate (pH adjusted to 4.8 by using ortho phosphoric acid) and methanol (30:70 v/v) as mobile phase in an isocratic elution mode at a flow rate of 1.0 mL min-1. The eluents were monitored by PDA detector at 245 nm. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Significant degradation was found under basic, acidic stress and UV light. The resolution (Rs) between amlexanox and its degradation products was found to be greater than 2.5. Regression analysis shows correlation coefficient greater than 0.999 for amlexanox. The inter and intraday precision values for amlexanox were found to be within 1.0% RSD. The method has shown good and consistent recoveries for amlexanox in bulk drugs (98.86% - 101.05%). The developed method was validated with respect to linearity, accuracy, precision and robustness.