Flurbiprofen loaded gel based topical delivery system: Formulation and in vitro characterization with new developed UPLC method

Abstract

Objective: The purpose of this study was to formulate flurbiprofen (FLB) loaded methylcellulose (MC), hydroxypropyl methylcellulose (HPMC) and Carbopol®940 (C-940) based gel formulations with the help of dispersion method for topical application. Additionally, in this study also a new ultra performance liquid chromatography method was developed for the determination of FLB, which was not previously entered into the literature. Method: FLB loaded gel formulations with the help of dispersion method for topical application and to characterize the formulations according to physical appearance, pH, rheology, drug content, dissolution study and release kinetic study with the DDSolver software program. The UPLC method developed was validated for linearity, specificity, precision, sensitivity, accuracy, range and robustness. Results: Linearity was determined to be at a concentration range of 5-50 µg.mL-1. The method developed for FLB was decided to be precise due to RSD values of >2%. Recovery of the method was satisfactory owing to >2%RSD value. The drug content was found to be in the range of 98.14-99.02% indicating the uniformity of the high drug content. At the 6th hour in dissolution study, the FLB release from gels prepared with MC, HPMC, C-940 reached 99.7%,99.5% and 87.60%, respectively. In the release kinetic tests with DDSolver, the release of gels prepared with MC and HPMC showed conformity with the weibull model, whereas the gel formulation prepared with C-940 showed a zero-order kinetics. Conclusion: According to the results, all gel formulations prepared have longer release times than the release of pure FLB