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Development and Validation of Stability-Indicating HPLC Method for Determination of Azilsartan Medoxomil in Pharmaceutical Dosage Form
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| Author:
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SANTOSH GANDHI, KADAM ASHWINI A, KARAD MADHURI M
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| Abstract:
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A simple, selective stability indicating high performance liquid chromatographic method for the analysis of Azilsartan medoxomil in bulk and in tablet dosage form has been developed and validated. Sample was resolved on HPLC system containing HiQ Sil C18 (250 mm X 4.6 mm i.d., 5 µ) column equipped with a PDA detector. The mobile phase consisted of methanol and water (pH 3 adjusted by o- phosphoric acid) in the ratio of 80:20 v/v at a flow rate of 1 ml/min and quantification at 250 nm. The retention time of Azilsartan medoxomil was 5.2 ± 0.02 minutes. The calibration curve was linear over the concentration range of 5-30 µg/ml (r2 = 0.998). The limit of detection for was found to be 0.059 µg/ml and the quantification limit was about 0.17 µg/ml. The accuracy of the method was established based on the recovery studies. The drug was subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. The proposed method can be applied to the routine analysis of Azilsartan medoxomil in bulk and in tablet dosage form.
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| Keyword:
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Azilsartan medoxomil, HPLC, Stability indicating method
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| DOI:
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