Validation of HPLC Method for Simultaneous Determination of Galantamine Hydrobromide/Pymadine

In accordance to the perspectives of multi-target therapy of Alzheimer's disease by the combination of acetylcholinesterase inhibitor with a potential synergist, and due to the fact that in literature and pharmacopoeial articles, the methods for the simultaneous analysis of Galantamine and Pymadine haven't been described, the aim of the current investigation was the development of isocratic HPLC method for the simultaneous determination of these drugs in the model mixtures and validation of method for the analytical parameters' selectivity, linearity, LOD, LOQ, accuracy and precision as per ICH requirements. The chromatographic conditions applied were: column RP C-18 ODC Spherisorb, column temperature: 25 degrees C, mobile phase: 50 mM disodium hydrogenphosphate: acetonitrile = 80 : 20 v/v, flow rate: 1.5 ml/min., UV-detection (lambda = 280 nm). The experimental results were subjected to a linear regression analysis. The regression equations obtained demonstrated the linear relationship between the peak area and concentration: y = 1.10(10).x + 387106 (Galantamine hydrobromide) (LOD = 1.08.10(-4) g/ml; LOQ = 3.6.10(-4) g/ml); y = 9.10(9).x + 1.10(6) (Pymadine) (LOD = 1.32.10(-4) g/ml; LOQ = 4.4.10(-4) g/ml). Accuracy was represented by the degree of recovery, which data were included in the corresponding confidence interval: 96.66 % divided by 98.76 % (Galantamine hydrobromide); 99.58 % divided by 103.86 % (Pymadine). The results for precision suited the relevant interval: System suitability was confirmed by the lack of statistically significant difference between retention time values: t(R) = 3.179 (Galantamine hydrobromide), t(R) = 5.272 (Pymadine). The developed and validated isocratic HPLC method was appropriate for separation, and simultaneoully for identification and determination of Galantamine hydrobromide and Pymadine, for which, the combination HPLC methods haven't been described previously.