Development And Validation of Rp-Uplc Method For Simultaneous Estimation Of Iloperidone And Idebenone In Sublingual Bilayer Tablets

Aim: Establishing and validating the stability indicating Reverse-Phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for simultaneous measurement of Iloperidone and Idebenone in sublingual bilayer tablets is the main goal of this research work. Methods: Acetonitrile as the mobile phase, 0.1% v/v orthophosphoric acid in water, a flow rate of 0.4 ml/min, and a detection wavelength of 240 nm were all necessary for the successful separation of Iloperidone and Idebenone utilizing an HSS column C18 (100 X 2.1 mm). According to ICH requirements, the stability of the active ingredients in mixed powder and sublingual bilayer tablets was evaluated under extreme circumstances such as heat degradation, peroxide oxidation, and acid-base hydrolysis. Results and Discussion: Iloperidone and Idebenone are pharmaceutically significant combinations recommended in the treatment of numerous psychiatric and neurological conditions. Articulating these compounds into sublingual bilayer tablets enhances their bioavailability and efficacy. Therefore, an accurate and precise analytical method is imperative for their simultaneous estimation to ensure product quality and therapeutic effectiveness. Iloperidone and Idebenone had different retention times, with Iloperidone at 0.49 min and Idebenone at 0.93 min. The proposed method shows linear responses for Iloperidone (5–30 μg/mL) and Idebenone (2.5–15 μg/mL) within concentration ranges. The calculated limits for detecting and measuring Iloperidone were 0.22μg/mL & 0.47μg/mL, respectively, while for Idebenone they were 0.12μg/mL & 0.36μg/mL. All the validation parameters for the method confirmed according to the ICH Q2 acceptance limits.  Significant resolution between Iloperidone, Idebenone, and their degradation products has been noted in the methodology's stability aspect. Conclusion: The proposed RP-UPLC method demonstrated high sensitivity, precision, and stability indication, making it a potentially viable technique for the simultaneous estimation of Iloperidone and Idebenone in sublingual bilayer tablets.