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A first-derivative spectrophotometric (1D) method and a derivative-ratio zero-crossing spectrophotometric (1DD) method were used to determine pyritinol dihydrochloride (I) in the presence of its precursor (II) and its degradation product (III) with 0.1N hydrochloric acid as a solvet. Linear relationships were obtained in the ranges of 6–22 μg/mL for the (1D) method and 6–20 μg/mL for the (1DD) method. By applying the proposed methods, it was possible to determine pyritinol dihydrochloride in its pure powdered form with an accuracy of 100.36 ± 1.497% (n = 9) for the (1D) method and an accuracy of 99.92 ± 1.172% (n = 8) for the (1DD) method. Laboratory-prepared mixtures containing different ratios of (I), (II), and (III) were analyzed, and the proposed methods were valid for concentrations of ≤10% (II) and ≤50% (III). The proposed methods were validated and found to be suitable as stability-indicating assay methods for pyritinol in pharmaceutical formulations.

journal of aoac international

Stability-Indicating Methods for Determination of Pyritinol Dihydrochloride in the Presence of Its Precursor and Degradation Product by Derivative Spectrophotometry