Abstract

DISSOLUTION STUDIES OF IRBESARTAN TABLETS BY UV-VISIBLE SPECTROMETRY

Premalatha and NJR. Hepsebah*

ABSTRACT

Objective:- The main aim of the article is to develop a simple, precise and accurate dissolution method for irbesartan tablets by uv spectrometry and to validate the method as per ICH guidelines. Method:- Irbesartan is a medication used to treat high blood pressure, heart failure, and diabetic kidney disease. It is a reasonable initial treatment for high blood pressure. It is taken by mouth. The optimised dissolution method includes 1 N HCl as dissolution media, USP type 2(paddle) as dissolution apparatus, rpm as 100, temperature of dissolution media is 37±0.5ºC, dissolution volume as 500ml, dissolution time point to be 30 minutes, working concentration of standard and sample as 5 μg/ml and a detection wavelength of 233 nm. Results:- The developed method resulted in irbesartan exhibiting the following validation parameter values-linearity to be in the range 2-15μg/ml with LOD and LOQ values to be 198ng/ml and 734ng/ml. System precision and method precision acknowledge the criteria as the relative standard deviation values are within 2%. The method is rugged and precise. The method is accurate as the percentage mean recovery is more than 80%. Conclusion:- Thus, as the method approves all the validation parameters- this method is effective for dissolution studies of irbesartan in routine lab analysis.

Keywords: Irbesartan, validation, ICH, USP, dissolution method.