Abstract
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.
Highlights
Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been evaluated for the treatment of recurrent aphthous ulcers (RAU) and is currently the only clinically proven product approved by the US FDA for the treatment of aphthous ulcers
Peak purity test results derived from Photo diode array detector of Waters (PDA) detector, confirmed that the amlexanox peak was homogeneous and pure in all the analyzed stress samples
The Stability Indicating RP-LC method developed for quantitative determination of amlexanox in bulk drugs is precise, accurate and specific
Summary
Amlexanox is a novel anti-inflammatory and anti-allergic agent that has been evaluated for the treatment of recurrent aphthous ulcers (RAU) and is currently the only clinically proven product approved by the US FDA for the treatment of aphthous ulcers. Amlexanox effectively treats aphthous ulcers by accelerating healing of ulcer and by accelerating complete resolution of pain. Amlexanox is commercially available as 5% oral paste and as biodegradable muco-adhesive disc. Amlexanox potently inhibits the release of histamine and leukotrienes from mast cells, basophils and neutrophils under invitro settings, possibly through increasing intracellular cyclic AMP content in inflammatory cells, a membrane-stabilizing effect or inhibition of calcium influx [1,2,3,4,5]
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