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Title : A VALIDATED RP-HPLC METHOD FOR DETERMINATION OF ALISKIRIN AND AMLODIPINE IN TABLET DOSAGE FORM
Authors : *Venkata Raveendra Babu Vemula, Pankaj Kumar Sharma
Abstract : A simple, accurate, rapid, precise, specific and cost effective reverse phase high performance liquid chromatography (RP-HPLC) method have been developed and subsequently validated for simultaneous estimation of Aliskiren and Amlodipine in pharmaceutical dosage forms. Chromatography is carried out isocratically at 30°C ± 0.5°C on an Water’s X-bridge C-18 column (4.6 x 150mm, 5μ particle size) with a mobile phase composed  of  acetonitrile -phosphate  buffer  (pH-2.5)  (40:60, v/v)  at  a  flow rate  of  1.0  mL/min. Detection  was carried out using a PDA detector at 230 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization guidelines. The retention times for Aliskiren and Amlodipine are 3.8 min and 5.1 min respectively. The linearity range for Aliskiren and Amlodipine are 18.75-187.5µg/ml and 1.25-12.5 µg/ml respectively. The correlation coefficients for both components are close to 1. The relative standard deviations for six replicate measurements of samples in tablets are always less than 2%.

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