Development and Validation of HPLC Method For Quantitative and Qualitative Analysisof Asenapine Maleate from Polymeric Micelles

Abstract

  The precise and confirmed HPLC technique has been established to quantify Asenapine maleate (ASPM) concentration in polymeric micelles. The separation was performed using a C18 analytical column with a mobile phase comprised of acetonitrile: water with 0.2% TFA 50:50 v/v. Flow rate of mobile phase was 1 mL/min, with a UV detector set to a wavelength of 230 nm. Various analytical considerations such as linearity, sensitivity, precision and others, are essential for validating strategies to provide consistent, dependable, and precise findings. The analytical approach had been utilized to ascertain the ASPM level in polymeric micelles formulations. The assay was specific, exhibiting a retention time of 4.72± 0.08 minutes. Linearity was achieved throughout the concentration range of 10mg/mL to 150 mg/mL. The established method is applicable for the assessment of ASPM polymeric micelles, including all of the method validation criteria, which are all within the permissible range.