European Journal of Biomedical and Pharmaceutical Sciences

STABILITY-INDICATING SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF NICLOSAMIDE IN PURE FORM AND PHARMACEUTICAL PREPARATION

Khalid Abdel-Salam Attia, Mohammed W.I. Nassar and Ahmed W. Madkour*

ABSTRACT

Four Simple, rapid, sensitive, accurate and precise stability-indicating spectrophotometric methods were developed for the determination of Niclosamide in bulk powder and in pharmaceutical preparation. Method (A) double divisor ratio difference method ;is based on measuring the difference in the amplitude of intact Niclosamide in presence of its degradation products at two different wavelengths ,this is done at 324 nm and 337 nm in the range of 3 – 21 μg ml-1 with LOD of 0.573μg ml-1 and LOQ of 1.737 μg ml-1.,Method (B) absorbance ratio method, is used for the determination of intact Niclosamide in presence of its degradation products, this is done at 330.8 nm (λ max ) and 348.8 nm (λ iso ) in the range of 3-21μg ml-1 with LOD of 0.16 μg ml-1 and LOQ of 0.485 μg ml-1 at (330.8nm) and with LOD of 0.216 μg ml-1 and LOQ of 0.656 μg ml-1 at (348.8 nm ), Method (C) mean centering method; the method was applied for analysis of Niclosamide in presence of its degradation products this is done at 356 nm in the range of 3 – 21 μg ml-1 with LOD of 0.263 μg ml-1 and LOQ of 0.797 μg ml-1, Method (D) Bivariate method, is used for the determination of intact Niclosamide in presence of its degradation products at 330&350 nm in the range of 3 – 21μg ml-1 with LOD of 0.11 μg ml-1 and LOQ of 0.334 μg ml-1 at (330 nm) and with LOD of 0.134 μg ml-1 and LOQ of 0.406 μg ml-1 at (350 nm)The obtained results were statistically compared with those of the reported method by applying t-test and F-test at 95% confidence, level and no significant difference was observed regarding accuracy and precision.

Keywords: Niclosamide, Double divisor, Ratio difference, Absorbance ratio, Mean centering, Bivariate, pure form, pharmaceutical preparation.