Rapid Analytical Technique for the Quantification of Specified and Unspecified Impurities Present in Amlodipine besylate and Olmesartan medoxomil Fixed Dose Combination Drug Product Using Ethylene-Bridged RP-UPLC Column

Abstract

The current research work describes about well thought out development and validation of liquid chromatographic method for simultaneous determination of specified and unspecified impurities present in Amlodipine besylate and Olmesartan medoxomil fixed dose combination drug product. Reverse phase-Ultra Performance liquid chromatography (RP-UPLC) technique has been chosen for faster separation between impurities. Effective and rapid separation between impurities at satisfactory level is achieved using Acquity UPLC BEH C8, 100 mm length x 2.1 mm ID column with 1.7 mm particle size. Flow gradient elution mode was kept using 0.1% orthophosphoric acid in water as Mobile phase A and acetonitrile as Mobile phase B. Initial flow rate was kept at 0.5 mL.min-1 followed by gradual increase to 0.7 mL.min-1 to elute non polar eluents from Amlodipine besylate and Olmesartan medoxomil with a monitoring wavelength of 237 nm. Developed method was successfully validated as per pharmacopeia and general recommendation given for validation study as specified in ICH for specificity (stress study), precision, accuracy, linearity, determination of Limit of Detection (LOD) & Limit of Quantification (LOQ), solution stability and robustness. The developed and validated method requires less consumption of solvents with shorter run time of 15 minutes results in a rapid, precise, sensitive, cost and time effective method for the quantitative determination of Amlodipine besylate and Olmesartan medoxomil impurities in Amlodipine besylate and Olmesartan medoxomil tablets dosage forms helping to improve quality control and to assure therapeutic efficacy.