VALIDATION OF THE QUALITATIVE DETERMINATION OF HPLC METODS FOR SUCROSE AND PEG-2000-DSPE IN A LIPOSOMAL FORM OF THE PHOTOSENSITIZER LIPOPHTHALOCYAN
Keywords:HPLC, Sucrose, PEG-2000-DSPE, Lipophthalocyan, Validation
Objective: This study was undertaken with the aim of the validate the 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 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 were validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed methods are sensitive, precise, reliable and simple for the estimation of PEG-2000-DSPE and sucrose in Lipophthalocyan.
Lantsova AV, Borisova LM, Meerovich GA, Bunyatyan ND, Olefir YV, Prokof’ev AB, et al. Analysis of antitumor activity of the liposomal photosensitizer lipophthalocyan. Bull Exp Biol Med 2020;168:361-5.
Tatode AA, Patil AT, Umekar MJ. Application of response surface methodology in optimization of paclitaxel lipodomes prepared by thin film hydration technique. Int J Appl Pharm 2018;10:62-9.
Roces CB, Kastner E, Stone P, Lowry D, Perrie Y. Rapid quantification and validation of lipid concentrations within liposomes. Pharmaceutics 2016;8:29.
Athmakur H, Kondapi AK. Carmustine loaded lactoferrin nanoparticles demonstrates and enhanced antiproliferative activity against glioblastoma in vitro. Int J Appl Pharm 2018;10:234-41.
Laouini A, Jaafar Maalej C, Limayem Blouza I, Star S, Charcosset C, Fessi H. Preparation, characterization and applications of liposomes: state of the art. J Colloid Sci Biotechnol 2012;1:147-68.
Lantsova AV, Olefir YV, Bunyatyan ND, Sanarova EV, Orlova OL, Dmitroeva MV, et al. Validation of a method for assay of excipients in liposomal medicinal formulations of the photosensitizer lipophthalocyan. Pharm Chem J 2020;53:986–90.
Sharma S, Goyal S, Chauhan K. A review of analytical method development and validation. Int J Appl Pharm 2018;6:8-15.
ICH, Q2 (R1) Validation of analytical procedure, text and methodology. International Conference on Harmonization; 2016.