Abstract
Background: Smart different stability-indicating spectrophotometric methods have been established for the assay of chlordiazepoxide and clidinium bromide without the intervention of alkaline degradate of clidinium via various and different manipulating pathways without previous separation steps.
Objective: The specificity of the established methods was inspected by analysing mixtures of cited drugs in the existence of the alkali-induced degradation product.
Methods: These methods were employed either on scanned zero-order absorption spectra using absorbance subtraction, dual wavelength and Q-absorbance ratio or the amplitudes of the ratio spectra of zero-order absorption spectra like amplitude modulation and by derivative techniques to the ratio spectra as a derivative ratio method. In addition, the absorbance of the recovered zero-order absorption spectra was applied by successive ratio subtraction coupled with constant multiplication. Finally, the pathway depends on the amplitudes of the derivative spectra, successive derivative subtraction coupled with constant multiplication. The ranges of linearity were (1-12µg/mL) for chlordiazepoxide and (3- 12µg/mL) for clidinium bromide.
Results: The outcomes achieved by the prospective methods were in consent with those of the official and reported methods when statistically compared using student’s t test, F-test and one-way ANOVA where no significant difference was detected with suitable precision, proving the absence of any important difference in accuracy and precision between them. They were confirmed in accordance with International Conference on Harmonization guidelines.
Conclusion: The established methods can be considered as alternative methods for the routine determination of this fixed dose combination with minimum sample preparation.
Keywords: Stability-indicating, absorbance subtraction, amplitude modulation, successive derivative subtraction, dual wavelength, Q-absorbance ratio, chlordiazepoxide and clidinium bromide.
Graphical Abstract
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