VALIDATION OF THE QUALITATIVE DETERMINATION OF HPLC METODS FOR SUCROSE AND PEG-2000-DSPE IN A LIPOSOMAL FORM OF THE PHOTOSENSITIZER LIPOPHTHALOCYAN
Objective: This study was undertaken with the aim of the validate the a simple isocratic metods high performance liquid chromatographic (HPLC) for the estimation of PEG-2000-DSPE and sucrose in liposomal medicinal formulations of the phthalocyanine photosensitizer Lipophthalocyan.
Methods: HPLC quantification was carried out by using of YMC-Pack Polyamine II column. The mobile phase (for sucrose: acetonitrile: water : ethyl acetate in the ratio of 450 : 200 : 20; for PEG-2000-DSPE: water : Н2О in the ratio 10 : 90) was pumped at a flow rate of 1 ml/min. Following the guidelines of the International Conference on Harmonization (ICH), the methods was validated for various analytical parameters like specificity, linearity, detection limit, quantitative limit, correctness, and accuracy.
Results: The obtained results of the analysis were validated statistically. The correlation coefficient for the linearity was 0,999292, for sucrose, and 0,997650 for PEG-2000-DSPE. The methods can be assessed as correct, as the results obtained are close to the true value and the confidence interval for both methods include 100%. The coefficients of variation in both methods in determining the accuracy were less than 3%.
Conclusion: The proposed HPLC methods was validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed methods is sensitive, precise, reliable and simple for the estimation of PEG-2000-DSPE and sucrose in Lipophthalocyan.
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