Development and Method Validation of Design of Experiments-Optimized Tablet Formulation for Simultaneous Detection of Exemestane and Everolimus.

ABSTRACT

The development and analysis of pharmaceutical formulations often involves the determination of multiple active ingredients in a dosage form. The aim of the present study is to develop a convenient method for simultaneous estimation of Exemestane (EXE) and Everolimus (EVE) in bulk and in systemically designed tablet dosage form. Methanol was used as a solvent for developing linear curves and validated in terms of various parameters, such as selectivity, sensitivity, linearity, precision, accuracy, and robustness. Method validation observed that the proposed method is reliable and reproducible, meeting the regulatory requirements for pharmaceutical analysis with a relative standard deviation of <2%. The developed method was found to be sensitive and selective in simultaneous equation method. The unknown concentrations of EVE and EXE were found to be 10.431 and 10.232, respectively. The next step is to systematically design a tablet formulation for EXE and EVE containing ß-cyclodextrin as a polymer. Microcrystalline cellulose (X1), sodium starch glycolate (X2), and beta-cyclodextrin (X3) are the critical variables and hardness (Y2) and friability (Y3) were selected as prime responses. Analysis of variance provides significance of the model, and the predicted batch gives a high desirability value of 0.862. In vitro dissolution profiles of optimized batch (OB1) were signified by high drug release profile as 89.47% and 96.00% for EVE and EXE in tablet formulation, as compared with pure API, respectively. This study signifies enhancement in biopharmaceutical attributes of EXE and EVE in tablet formulation and robust simultaneous estimation by the UV method. In a nutshell, this study provides the simultaneous estimation method in tablet dosage form, and further research is crucial for the advancement of pharmaceutical analysis and the formulation of effective medicines.