Abstract
Purpose : A new stability-indicating RP-HPLC assay method for estimation of indomethacin and its degradation products formed under various stress conditions was developed and validated for routine analysis of indomethacin in its marketed dosage forms. Methodology : The method uses a volatile buffer and could be extended for LC-MS studies. The separation was carried out on Zorbax Eclipse Plus C18, 3.5 μm (4.6 mm × 100 mm) column with acetonitrile: 10 mM sodium acetate buffer pH 4, 60:40% v/v as the mobile phase at the flow rate of 0.5 ml/min with detection carried out using UV-Visible PDA detector at 226 nm. The retention time of indomethacin was 5 min and linearity was observed in the concentration range of 7.5-75 μg/ml. The developed method was validated as per the ICH guidelines. The drug was subjected to various stress conditions of acid and base hydrolysis, oxidation, photolysis, thermal degradation and neutral condition. Findings : Considerable degradation was found under all stress conditions and the degradation products were well resolved from indomethacin in the proposed HPLC method. Conclusion: The new method could be used for routine analysis of indomethacin in its dosage forms. The model used for stress degradation studies is simple and could be extended for study of other drug molecules.
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