DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN MEDOXOMIL AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORM
Nita Yadav*, Anju Goyal and Rajesh Yadav
ABSTRACT
An isocratic RP-HPLC method was developed and validated for simultaneous estimation of Azilsartan medoxomil
and Amlodipine besylate in tablet dosage form. The chromatographic separation was carried out on C18 Inertsil
ODS column (250 X 4.6 mm, 5μm particle size) with mixture of 0.1% TFA and ACN in ratio of 75:25, v/v as a
mobile phase; at a flow rate of 1.0 mL/min. UV detection was performed at 245 nm. The retention time was found
to be 4.626 min and 2.222 min for azilsartan medoxomil and amlodipine besylate, respectively. Calibration plots
were linear over the concentration range of 4-20 μg/mL and 1-5 μg/mL for azilsartan medoxomil and amlodipine
besylate, respectively. The method was validated for linearity, accuracy, precision, repeatability, LOD and LOQ.
The proposed method was successfully used for quantitative estimation of azilsartan medoxomil and amlodipine
besylate. Percentage recovery within the limit of 98-102 % and low relative standard deviation confirm the
suitability of the proposed method for routine estimation of azilsartan medoxomil and amlodipine besylate in
tablet dosage form.
Keywords: RP-HPLC, Azilsartan medoxomil, Amlodipine besylate.
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