STABILITY-INDICATING SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF RISPERIDONE IN PURE FORM AND PHARMACEUTICAL PREPARATION.
Khalid Abdel-Salam Attia, Ahmad Abdelhalim Mohamad and Mohamed Saleh Emara*
ABSTRACT
Three simple, rapid, sensitive, accurate and precise methods were developed for the determination of risperidone in bulk powder, in pharmaceutical preparation and in presence of its degradate.Method (A) ratio difference method; is based on measuring the difference in the amplitude of intact risperidone in presence of its degradation product at two different wavelengths, this is done at 240 nm and 287 nm in the range of 5 – 35 μg ml-1 with LOD of 0.0053 μg ml-1 and
LOQ of 0.018 μg ml-1.Method (B) mean centering method; the method was applied for analysis of risperidone in presence of its degradation product this is done at 285.6 nm in the range of 5 – 35 μg ml-1 with LOD of 0.161 μg ml-1 and LOQ of 0.535 μg ml-1. Method (C) Derivative ratio method(1DD); is used for the determination of intact risperidone in presence of its degradation product at 231 nm in the range of 5 – 35 μg ml-1 with LOD of 0.087 μg ml-1 and LOQ of 0.289 μg ml-1. 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: Risperidone, Ratio difference, Mean centering, Derivative ratio.
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