Validated High Performance Liquid Chromatography Method for the Quantification of Loteprednol Etabonate in Self Micro Emulsifying Drug Delivery Systems

Background: The objective of this work is to develop and validate a reverse-phase HPLC method for determining Loteprednol Etabonate in self micro emulsifying drug delivery systems at nanogram level. Methods: A systematic approach has been implemented for the optimization of chromatographic conditions. The developed reverse-phase HPLC method was validated for linearity, accuracy, precision, limit of detection and quantification, extraction recovery, specificity (matrix effect and forced degradation studies), and robustness. The method was also investigated for the estimation of Loteprednol under forced degradation for acid, base, thermal and oxidative conditions. Results: The developed method showed linearity between 200 and 12000 ng/mL with R-2 value of 0.998. The detection and quantification limits were determined to be 60 and 180 ng/mL, respectively. The % recovery and % RSD of the developed method were 99.00 % to 101.79 % and 0.0459 % - 0.6470 %, respectively. The validated method was able to identify the degradants and formulation excipients interactions at the drug peak retention time (4.7 min). The assay determination in lipid emulsion formulations was successfully carried out using the established method. The % recovery of loteprednol etabonate from formulations has shown good agreement without any interference. Conclusion: The validated stability-indicating analytical method was useful for the quantification of loteprednol etabonate in self micro emulsifying drug delivery systems.