DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RELATED SUBSTANCES OF LISDEXAMPHETAMINE DIMESYLATE BY RP-HPLC

Abstract

Reversed phase high performance liquid chromatography method, for estimation of related substances or chromatographic impurities of
lisdexamphetamine dimesylate was developed and validated. A selected wavelength maximum for lisdexamphetamine dimesylate was 210nm. All
peaks were well separated under selected chromatographic conditions. YMC Pack C18 (150 x 4.6), 5µm column was used for separation of
lisdexamphetamine dimesylate and its related impurities. 1.0 mL/min flow rate and 55
0C column compartment temperature was the chromatographic
conditions. Validation of Developed method was performed according to ICH (Q2R1). Linearity plot for lisdexamphetamine and its related impurities
showed good concentration ranges 0.6ppm-2.4ppm for lisdexamphetamine and 0.6ppm- 3.6ppm for lisdexamphetamine dimesylate showed linear
relation between concentration and peak areas, correlation coefficient for all components were within acceptance limit as >0.99. The precision of
method was determined by method, system and intermediate precision which show % RSD under limits (<10%) for all impurities and
lisdexamphetamine dimesylate. LOD and LOQ for all impurities and lisdexamphetamine dimesylate was 0.01% and 0.03% respectively with respect
to test concentration. Accuracy was calculated as percentage recovery which was under acceptance criteria (90-110%) for all related impurities of
lisdexamphetamine dimesylate. The robustness study was performed for flow rate variations (+0.1 mL/min) and column temperature variations
(+5.0oC), changes in retention time and resolution was negligible. The proposed method is simple as selected chromatographic conditions are not so
difficult to apply in routine analysis for testing the chromatographic impurity of lisdexamphetamine dimesylate.