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Validation parameters of densitometric method for simultaneous determination of Galantamine hydrobromide and Pymadine


Dobrina Tsvetkova , Stefka Ivanova

Abstract

The aim of the current investigation was the development and validation as per ICH requirements of the TLC-densitometric method with the detection at λ = 282 nm for the simultaneous determination of Galantamine hydrobromide and Pymadine in model mixtures. The aim was in accordance to the perspectives of multi-target therapy of Alzheimer’s disease, and due to the fact that in the literature and pharmacopoeial articles the methods for simultaneous analysis of these components haven’t been described. Selectivity was confirmed by the fact that in blank solution, Rf data weren’t observed corresponding to Rf data of the active ingredients. The regression equations obtained demonstrated the linear relationship between the peak area and concentration: y = 2.107.x + 25364 (Galantamine hydrobromide) (LOD = 1.87.10-3 g/ml; LOQ = 6.22.10-3 g/ml); y = 2.107.x + 65930 (Pymadine) (LOD = 2.5.10-3 g/ml; LOQ = 8.35.10-3 g/ml). All the experimental data for the degree of recovery were included in the corresponding confidence interval: 93.54 % ÷ 97.32 % (Galantamine hydrobromide); 100.05 % ÷ 103.11 % (Pymadine). The results of precision suited the relevant intervals. System suitability was confirmed by the lack of a statistically significant difference between the Rf values: 0.663 (Galantamine hydrobromide); 0.433 (Pymadine). The method was appropriate for the simultaneous determination of Galantamine hydrobromide and Pymadine in the model mixtures.



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