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Development and Validation of an RP-HPLC Method for the Determination of the Candesartan Cilexetil in Tablet Dosage Forms

Author(s): G. Mani Kumar, A. Meechel, P. M. Vasantha Kumar, D. Anantha Kumar, N. Jyothi and J. V. L. N. Seshagiri Rao

A rapid and reproducible reverse phase high performance liquid chromatographic method has been developed for the determination of candesartan cilexetil from its dosage forms. The separation was effected on a C18 Kromasil column (150 x 4.6 mm; 5 µ) using a mobile phase consisting of water, acetonitrile and trifluoro acetic acid in the ratio of 48 : 52 : 0.1 v/v at a flow rate of 1.5 mL/min. The retention time of the drug was found to be 5.54 min. The method produced linear responses in the concentration range of 25-200 µg/mL of the drug. The proposed method was validated as per the ICH guidelines. The method is accurate and precise and is found to be suitable for the quantitative analysis of the drug in its tablet dosage forms.

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