Method Development and Validation for the Determination of Potential Impurities Present in Azilsartan medoxomil Tablets by Reverse Phase-Ultra Performance Liquid Chromatography

Abstract

The present paper describes about precise, sensitive, rapid method for the determination of five potential impurities present in Azilsartan medoxomil Tablets. Separation of impurities at satisfactory level is achieved in Acquity UPLC BEH C₁₈, 100 mm length x 2.1 mm id with 1.7 µm particle size column. Mobile phase A consists of 0.1% ortho phosphoric acid in water adjusted the pH to 3.0 with dilute sodium hydroxide and acetonitrile as Mobile phase B using gradient elution mode. Flow rate was kept at 0.5 mL.min^-1 with a monitoring wavelength of 215 nm. Developed method was successfully validated as per method validation parameters recommended by International Conference on Harmonisation (ICH) for specificity, linearity, precision, accuracy, determination of LOD, LOQ, solution stability and robustness. The validated Reverse phase-Ultra Performance Liquid Chromatography (RP-UPLC) method was successfully used for quantitative determination of potential known and unknown impurities of Azilsartan medoxomil in Azilsartan medoxomil tablet dosage form, helping to identify the therapeutic efficacy at shorter run time.

Key words:

• Azilsartan medoxomil
• Forced Degradation
• RP-UPLC and Stability Indicating