Abstract
Irbesartan, chemically, a non peptide tetrazole derivative, has anti hypertensive property. It is an angiotensin II antagonist that selectively blocks the binding of an angiotensin II to the angiotensin I receptor. In present work, a selective, specific, sensitive and economical hydrotropic agent assisted spectroscopic method using 1M sodium bicarbonate and 2M urea (50:50% v/v), as hydrotropic agent; to increase the solubility of poorly water-soluble Irbesartan, has been developed for the estimation of Irbesartan in Bulk and its pharmaceutical dosage forms. An absorption maximum was found to be at 246.4 nm where sodium bicarbonate, urea and other excipients did not show any absorbance above 228 nm and thus no interference in the estimation. Irbesartan was obeyed Beer’s law in the concentration range from 10-35 μg / ml. Proposed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values with correlation coefficient of 0.9998. The percentage recovery of Irbesartan ranged from 99.4-101.3% in pharmaceutical dosage form. Results of the analysis for accuracy, precision, LOD, LOQ and were found to be satisfactory. The proposed method is simple, rapid and suitable for the routine quality control analysis.
Highlights
Irbesartan is practically insoluble in water so hydrotropic agents utilized to increase the water solubility [3]
To the best of our knowledge, there is no work in the literature reported about the Spectrophotometric method for the analysis of Irbesartan using hydrotropic agent
It was thought worth wile to employ these hydrotropic solutions to extract out the drug from fine powder of tablets to carry out Spectrophotometric estimation
Summary
Irbesartan, a non peptide tetrazole derivative, has anti hypertensive property [1]. Irbesartan is practically insoluble in water so hydrotropic agents utilized to increase the water solubility [3]. The solubility of various poorly water-soluble drugs was increased by hydrotropic solubilization phenomenon [4]. Literature survey reveals that various analytical methods had been developed such as HPLC [5], UV-Visible spectrophotometry [6], liquid chromatography [7] in biological fluids and in pharmaceutical formulations. To the best of our knowledge, there is no work in the literature reported about the Spectrophotometric method for the analysis of Irbesartan using hydrotropic agent. It was thought worth wile to employ these hydrotropic solutions to extract out the drug from fine powder of tablets to carry out Spectrophotometric estimation
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