Stability indicating determination of Albendazole in bulk drug and pharmaceutical dosage form by chromatographic and spectrophotometric methods

Abstract

Two sensitive stability indicating methods were developed for the determination of Albendazole in bulk drug and pharmaceutical dosage form, in presence of its alkaline-degradation product without any interference. The first one was isocratic HPLC method; using Agilent Zorbax Extend C-18 (150 × 4.6 mm, 5 μ) column, ' KH2PO4 solution and acetonitrile' in the ratio of (15:85v/v) as a mobile phase with a flow rate 0.6 ml min −1 and UV-detection at 295.0 nm, where the investigated drug could be quantized in a concentration range 1.00–50.00 μgml−1 with regression coefficient (r) of 0.9989. On the other hand, the second adopted method was derivative ratio spectrophotometry; where Albendazole could be determined in a concentration range 2.00–20.00 μg ml−1 at 281.4 and at 292.6 nm-296.8 nm (Peak-to-Peak difference) with a mean percentage recovery of 100.84 and 99.88 and with regression coefficient (r) of 0.9998 and 0.9999, respectively. The utilized methods were validated according to International Conference Harmonization (ICH) guidelines and successfully applied for analysis of bulk powder and pharmaceutical dosage form. All the obtained results were statistically compared to the chromatographic reported method and no significant difference was found; indicating the accuracy, sensitivity and reproducibility of the used methods. Keywords: Albendazole, Alkaline degradation product, Derivative ratio spectrophotometry, Isocratic HPLC method, Stability indicating