Abstract
Objective: The objective of the proposed method was to develop an accurate, rapid and cost-effective stability indicating a reversed phase high-performance liquid chromatographic method for the determination of azilsartan medoxomil. Materials and Methods: Chromatographic separation of the analyte from its degradation products was achieved on Qualisil- Gold column with a mobile phase composition of Acetonitrile and 0.2% Triethyl amine[pH 3.0], [62:38%v/v] at flow rate was 1.0 ml/min, the eluents were monitored using PDA detector at 248 nm. Results: The method was linear (r2 = 0.9997) in the concentration range of 20-120 μg/ml with acceptable percentage relative standard deviations for Inter-day (0.22 %) and Intraday (0.31 %) precisions. The result for accuracy study was 99.92-100.29 %. Conclusion: The method has proven specificity to quantify azilsartan medoxomil in presence of its degradation products formed in stress studies. Five major degradation products were found in stress studies, among them impurity-4 was identified and it was also observed that the drug was more susceptible to thermal and photolytic degradations. Key words: Stability indicating assay, Azilsartan medoxomil, RP-HPLC, ICH guidelines, Forced Degradation, Validation.
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