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

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

ABSTRACT

Four Simple, rapid, sensitive, accurate and precise stability-indicating spectrophotometric methods were developed for the determination of Gliclazide in bulk powder and in pharmaceutical preparation. First method is Derivative ratio method (1DD); is used for the determination of intact Gliclazide in presence of its degradation product at 244.4 nm in the range of 2 – 20 μg ml-1 with LOD of 0.299 μg ml-1 and LOQ of 0.908 μg ml-1 ., second method is ratio difference method; is based on measuring the difference in the amplitude of intact Gliclazide in presence of its degradation product at two different wavelengths ,this is done at 220 nm and 239 nm in the range of 2 – 20 μg ml-1 with LOD of 0.383 μg ml-1 and LOQ of 1.161 μg ml-1., third method is mean centering method; the method was applied for analysis of Gliclazide in presence of its degradation product this is done at 240 nm in the range of 4 – 20 μg ml-1 with LOD of 0.391 μg ml-1 and LOQ of 1.187 μg ml-1., fourth method is Bivariate method; is used for the determination of intact Gliclazide in presence of its degradation product at 210&225 nm in the range of 2 – 20 μg ml-1 with LOD of 0.258 μg ml-1 and LOQ of 0.782 μg ml-1 at (210 nm) and with LOD of 0.072 μg ml-1 and LOQ of 0.24 μg ml-1 at (225 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: Gliclazide, Ratio derivative, Ratio difference, Mean centering, Bivariate, pure form, pharmaceutical preparation


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