Abstract
The objective of the current investigation was to study the degradation behavior of levocetirizine under different ICH recommended stress conditions using HPLC and LC-MS and to establish a validated stability-indicating method. The drug was subjected to stress conditions of hydrolysis, photolysis, and thermal decomposition. Extensive degradation was found to occur in photolytic stress conditions. Mild degradation was observed in acidic, alkaline, and neutral conditions. The drug was stable to thermal stress condition. Successful separation of drugs from degradation products formed under stress conditions was achieved on a C-18 Supelco® Column using water-acetonitrile (50:50%v/v) as the mobile phase. The flow rate was 1.0 mL/min and the detection wavelength was 230 nm. The degradant products were characterized by LC-MS. The method was validated with respect to linearity, precision, accuracy, specificity, and robustness. The developed method efficiently separated the drug and degradation product in actual samples.
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