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ISSN 2063-5346
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A NEW VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IRBESARTAN AND ATORVASTATIN IN COMBINED TABLET DOSAGE FORMS

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Lalitha Repudi, M.Lakshmi Surekha

Abstract

The combination of Irbesartan and Atorvastatin is prescribed for the treatment of hypertension. To develop andvalidate HPLC Method for simultaneous estimation of Irbesartan and Atorvastatin Pharmaceutical formulations. Thechromatographic separation was performed on Shimadzu HPLC instrument on a Intersil C18 column (250 × 4.6 mm, 5 μm particle size) using A mixture of potassium dihydrogen phosphate (pH 3.5) and acetonitrile in the ratio of 30:70 v/v was used as the mobile phase and pumped at a flow rate of 1mL/min. The detector wavelength was set at 254 nm and flow rate of 1 mL/min. The developed method was validated according to ICH Q2R1 guideline. The linearity was established over a concentration range of 20-50 ng and 60-300 µg/mL with correlation coefficient r2 = 0.9995 and 0.9997 for Irbesartan and Atorvastatin, respectively. The Rt of Irbesartan and Atorvastatin were found to be 4.01±0.03 and 7.03±0.03 respectively. Recovery of drug was achieved in the range of 99.72–99.89% and 99.89–101.07% for Irbesartan and Atorvastatin, respectively by developed method. The LOD and LOQ of Irbesartan and Atorvastatin were found to be 316.92 and 2629 μg/mL, 104.58 and 722.1 μg/mL respectively. The developed HPLC method was applied for simultaneous estimation of two drugs in their synthetic mixture and results were found to be in good agreement with the labeled claim.The developed HPLC method was found to be accurate, precise, specific and sensitive. It can be applied for routine analysis (assay) of tablets containing combination of Irbesartan and Atorvastatin.

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