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Exploring Cosolvency in Analytical Method Development and Validation of Poorly Aqueous Soluble Candesartan Cilexetil in Bulk and Dosage Forms

Author(s): P. S. Yadav, A. A. Hajare*, R. S. Dhole and S. V. Dharangutikar
Department of Pharmaceutical Chemistry, 1Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra 416013, India

Correspondence Address:
A. A. Hajare, Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra 416013, India, E-mail:

The study was performed with a dual approach to develop and validate analytical method for poorly water soluble candesartan cilexetil by enhancing its solubility employing cosolvency technique. In order to enhance drug’s solubility based on its solubility characteristics, phosphate buffer (pH 6.8):ethanol (95 % v/v) mixture at 90:10 proportion was used along with Tween 80 (1 % v/v). Solubility of candesartan cilexetil in phosphate buffer (pH 6.8) enhanced due to the addition of co-solvent ethanol and Tween 80. Developed method obeyed Beer-Lambert’s law in the concentration range between 3-21 μg/ml. The regression coefficient at the wavelength 232 nm was 0.999. The analysis of tablets by the proposed method indicated a good correlation between estimated and label claims. Recovery studies showed that any small difference in drug concentration could be accurately determined. Low values of limit of detection and limit of quantitation indicated that the proposed method is sensitive, economic, accurate, precise, and robust for routine analysis of candesartan cilexetil in bulk and dosage forms.

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