Abstract
Stability testing on gliquidone was conducted under different conditions followed by adoption of two smart and selective spectrophotometric methods namely; mean centering of ratio spectra and derivative ratio for the determination of gliquidone in presence of alkaline degradation products. Degradation products have been elucidated by LC/MS and IR spectroscopy. The spectrum of alkaline degradation products (10 μg/ml) was chosen as a divisor to resolve the overlapped spectra of gliquidone and its degradation products. Mean centering of ratio spectra method depends on using Matlab software and measuring the mean centered values at 260 nm. Derivative ratio method is based on the measurements of analytical signal at 253 nm. Instrumental parameters and divisor concentration were carefully studied. The adopted methods have been validated as per International Conference on Harmonization guidelines. Linearity was obeyed in the range 1-18 μg/ml and detection limit was found to be 0.180, 0.324 μg/ml for mean centering of ratio spectra and derivative ratio methods, respectively. The recommended procedures were successfully applied for the analysis of Glurenor® tablets with good respective recoveries of 103.40± 0.50 and 102.99± 0.62. The results were statistically analyzed using student’s t-test and F-ratio to confirm accuracy and precision.
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