Hplc method development and validation for the simultaneous estimation of aliskiren and amlodipine in bulk and pharmaceutical dosage form

Padmini T and Satyanarayana L

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of aliskiren and amlodipine in bulk and capsule dosage form. A column of Altima (150mm 4.6mm; i.d and 5µ particle size) was used. The mobile phase comprises of 0.02M di potassium hydrogen orthophosphate buffer (pH adjusted to 3.1) and acetonitrile in the ratio of 15: 85 (v/v). The flow rate was 1.0 ml/min and the effluents were monitored at 250 nm. The retention time for aliskiren was 2.578min and amlodipine was 3.187min.The detection concentration was linear over 45-270ppm for aliskiren and 3-18ppm for amlodipine. Regression equation of aliskiren and amlodipine were found to be y = 19702x + 4807 and y = 86417x + 2088 respectively with regression co-efficient 0.999. The developed method was successfully validated in accordance to ICH guidelines. Hence, this method can be conveniently adopted for the routine analysis in quality control laboratories.

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DOI: http://dx.doi.org/10.24327/ijcar.2017.5049.0642