Stability indicating RP HPLC method for the determination of candisartan in pure and pharmaceutical formulation


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1

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4

Abstract :

An accurate and precise HPLC method was developed for the determination of candesartan Separation of the drug was achieved on a reverse phase C18 column using a mobile phase consisting of phosphate buffer and acetonitrile in the ratio of 30:70v/v. The flow rate was 1.2ml/min and the detection wavelength was 255 nm. The linearity was observed in the range of 20-60μg/ml with a correlation coefficient of 1.000. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, Peroxide and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability‐indicating one.
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