Analytical method development and validation for Candesartan Cilexetil as bulk drug and in pharmaceutical dosage forms by HPLC 

By V.Kamalakkannan , A. Puratchikody, K. Masilamani and T. Saraswathy 

ABSTRACT

A simple, sensitive and inexpensive isocratic reverse-phase liquid chromatographic method has been developed for quantitative determination of Candesartan cilexetil, as bulk drug and in pharmaceutical dosage forms. Chromatographic separation was achieved on an Octa Decyl Silyl column (C-18, 250 mm x 4.6 mm, 5 μm particle) with a 20:80 (v/v) mixture of phosphate buffer, pH 2.5, and acetonitrile as mobile phase. The flow rate was 1.0 mL / min and the detection wavelength was 215 nm. Resolution of Candesartan cilexetil was greater than 2.0.The drug was subjected to forced degradation such as photochemical oxidation, chemical oxidation, acid hydrolysis, base hydrolysis, different pH range, aqueous & non aqueous solution and thermal stress. The substantial degradation occurred in alkaline and acidic media and under oxidative and hydrolytic stress conditions and also in aqueous & non-aqueous hydrolysis. The method was validated for Accuracy, Precision, Specificity, Limit of Detection, Limit of Quantification and Linearity Range.

Keywords: Candesartan cilexetil, Antihypertensive, Liquid Chromatography, Forced degradation, Validation. 

Click here to download the complete article in PDF Format