Abstract
STABILITY-INDICATING BIVARIATE AND MULTI-VARIATE METHODS FOR DETERMINATION OF AMISULPRIDE IN PURE FORM AND PHARMACEUTICAL PREPARATION.

Khalid Abdel-Salam M. Attia, Mohammed Wafaa Nassar and
Ahmed Mohamed Abdel-Zaher*

ABSTRACT

Simple, accurate, sensitive and validated UV spectrophotometric and chemometric methods were developed for the determination of amisulpride in the presence of its acidic degradation products and in its pharmaceutical formulation. Method (A) Bivariate method; the method was applied for analysis of amisulpride in presence of its degradation product this is done at 215 nm and 240 nm in the range of 2 – 12 μg ml-1 with LOD of 0.164, 0.301 μg ml-1 and LOQ of 0.548, 1.002 μg ml-1, respectively. Method (B) Chemometric methods as principal component regression (PCR) and partial least-squares (PLS), classical least square (CLS), for the simultaneous determination of amisulpride in the presence of its acidic degradate, in pure form and in its tablets. The developed methods have the advantage of simultaneous determination of the cited components without any pre-treatment. 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: Amisulpride, Bivariate method, PCR, PLS and CLS.


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