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RP-HPLC method development and validation for the simultaneous estimation of imidapril HCl and amlodipine besylate in bulk and tablet.

Author(s)
Muhammad Saqlain Tahir Validation Department, Highnoon Laboratories Limited, Pakistan
Abstract
A simple reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of ImidaprilHCl and Amlodipine Besylate in combination. The separation was carried out using a mobile phase consisting of 0.01M potassium dihydorgen phosphate buffer (adjusted with 0.1% phosphoric acid to pH 3.0), acetonitrile and methanol in the ratio of 50: 35: 15. The column used was Lichrospher C18, 5µm, 25 cm × 4.6 mm maintained at 40°C with flow rate of 1 ml / min using PDA detection at 210 and 237 nm for ImidaprilHCl and Amlodipine Besylaterespectively. The described method was linear over a concentration range of 10-100 µg/ml and 14-140 µg/ml for the assay of ImidaprilHCl and Amlodipine Besylate respectively. The retention times of ImidaprilHCl and Amlodipine Besylate were found to be 4.3 and 6.7 min respectively. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and limit of quantification (LOQ) for ImidaprilHCl and Amlodipine Besylate were found to be 0.13 and 0.28 µg/ml and 0.24 and 1.47 µg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Amlodipine Besylate and ImidaprilHCl bulk drug and in its pharmaceutical dosage form.
Publication Details
Page(s) 49-51
DOI DOI not available
Published Journal: Journal of Chemical Society of Pakistan, Volume: 35, Issue: 1, Year: 2013

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