DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ASSESSMENT OF CALCIUM DOBESILATE IN VARIED HYDROGEL COMPOSITIONS

Standardized analytical methods for testing pharmaceutical preparations are not readily available in the literature for calcium dohesilate hydrogels. The aim of the study was to develop and validate an analytical method for methylcellulose gel containing calcium dobesilate as an active ingredient. Samples from dissolution experiments were assessed via HPLC with UV-VIS detector. The optimal composition of mobile phase included acetonitrile with water 1 : 1, acidified to 2.5 pH value. The applied column was Standard Purospher Star 18e 250 x 4.6 (5 mu m), and the maximum wavelength was set at 240 nm, at 25 degrees V. The total run time of analysis was set at 5 min and acquired retention time was 2.7 and 3.1 min for calcium dobesilate depending on the hydrogel formulation. A validity study of the method revealed that all obtained calibration curves showed good linearity (r(2) > 0.9927). Eight different calcium dobesilate hydrogel formulations were tested. Linearity (100% level) was found to be 99 - 101% for all formulations. Trueness was in the range of 98-102% on three different spike levels for all eight formulations. Precision results were around 100% with RSD lower than 1% in all cases indicating that the method can be used as a validated method. Limit of quantitation (LOQ) was found to be 13.25 eg/mL for all eight formulations. The method is feasible for evaluation of hydrophilic gels with calcium dobesilate.