Validated method for estimation of irbesartan in bulk and dosage form by high performance liquid chromatography technique

Abstract

A simple, specific, accurate and precise new high performance liquid chromatographic method was developed for the estimation of irbesartan in bulk and its developed dosage form. The mobile phase containing acetonitrile: Phosphate buffer pH 3.5 in proportion of 50:50 v/v was employed with flow rate of1.0 ml/min and eluting medium was monitored at 240 nm. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness for irbesartan. A linear response was observed in the range of 5- 40μg/ml. Linear regression of absorbance on concentration gave equation y = 101.9x + 195.3 with a regression co-efficient r2 =0.993. The method was validated for different parameters as per the ICH guidelines. The degradation studies were carried out by using the developed method. Thus the method was found to be useful for the determination of irbesartan in bulk as well as for dosage forms.