The present work describes development and validation of a specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of levocetirizine hydrochloride, as a bulk drug. The separation was achieved by using a mobile phase of acetonitrile: potassium dihydrogen phosphate buffer 0.1 M pH 3.5 (35:65, v/v) and Thermo BDS-hypersil column (250 mm X 4.6 mm, 5 μm) at flow rate of 1.0 ml/min. The detection was done at 230 nm. The retention time of levocetirizine hydrochloride was 7.3±0.01 min. This method has been successively applied to pharmaceutical dosage form. No chromatographic interference from the tablet excipient was found. Levocetirizine hydrochloride was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degraded products were well resolved from the pure drug with significantly different retention time values. Linearity was found to be in the range of 0.5–20 μg/ml with significantly high value of correlation coefficient. The method was validated for precision, robustness and recovery. The limit of detection and quantization were 0.129 μg/ml and 0.39 μg/ml. The acid degraded product of levocetirizine hydrochloride was subjected to LC-MS analysis. From the mass spectral data of degraded product, possible degradation pathway was outlined.
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