A specific, sensitive, precise and stability-indicating high-performance liquid chromatographic method of analysis of albendazole both as a bulk drug and in formulation was developed and validated. The separation was achieved by using a mobile phase of methanol: water pH 3 (85:15, v/v) and Chromatopak Peerless Basic-RP-C18 column at flow rate of 1.0 ml/min. The detection was done at 230 nm. The retention time of albendazole was 6 ± 0.01 min. This method has been successively applied to pharmaceutical dosage form. No chromatographic interference from the tablet excipients was found. Albendazole was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The drug was found to be stable only under thermal stress conditions; also 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 5–30 µg/ml with significantly high value of correlation coefficient. The method was validated for precision, robustness and recovery. The limit of detection and quantitation were 0.59 µg/ml and 1.8 µg/ml. The acid and base degraded products of albendazole were subjected to GC-MS analysis. From the mass spectral data of degraded products, possible degradation pathways were outlined.
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