Abstract
A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Irbesartan in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Ethyl acetate: Chloroform (6.5:3.5v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Irbesartan with the correlation coefficient of 0.9992. The regression equation was found to be Y=7.2733x+703.15. The Rf value of Irbesartan was found to be 0.55. The LOD and LOQ were found to 8.24 and 24.74 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Irbesartan in bulk and Pharmaceutical dosage form. Â
Highlights
Irbesartan is an angiotensin ΙΙ receptor antagonist used mainly for treatment of Hypertension
Irbesartan pure drug was obtained as gift sample from Apotex research private limited Bangalore and its pharmaceutical dosage form Irovel 150mg manufactured by Sun Pharma laboratories Ltd Assam
Calibration solutions were prepared by diluting the stock solution so that application of 2 μl volumes gave a series of spots covering the range 100 to 500 ng of Irbesartan
Summary
Irbesartan is an angiotensin ΙΙ receptor antagonist used mainly for treatment of Hypertension. It is a reasonable initial treatment for high blood pressure. It is an orally active nonpeptidetetrazole derivative and selectively inhibits angiotensin ΙΙ receptor. Angiotensin ΙΙ receptor type 1 antagonist has been widely used in treatment of disease like hypertension, heart failure, myocardial infarction and diabetic nephropathy [1]
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