ICH GUIDELINE PRACTICE: A VALIDATED STABILITY INDICATING RP-UPLC METHOD DEVELOPMENT AND ITS APPLICATION FOR DETERMINATION OF ALISKIREN AND AMLODIPINE IN BULK AND FORMULATION

A novel, accurate, specific and robust reverse phase liquid chromatographic method was developed and validated for the simultaneous estimation of Aliskiren and Amlodipine besylate in bulk and tablet dosage form. A reverse phase stability indicating Ultra High-Performance Liquid Chromatography (UHPLC) method was developed on an SD 3*100 mm x 1.8 μ column using isocratic elution of acetonitrile and 0.1% perchloric acid buffer (pH 2.6-2.8) in the ratio 60: 40 at a flow rate of 0.5 ml/min. The detection was carried out by using Acquity TUV ChA at 266nm. The total run time was 2.5 min and the retention time of amlodipine and Aliskiren were found to be 1.006 and 1.329 min respectively. According to ICH guidelines, forced degradation conditions were employed to establish the stability indicating method. The LOD and LOQ of Aliskiren and Amlodipine were found to be 0.17 μg/ml, 0.51 μg/ml and 0.03 μg/ml, 0.10 μg/ml respectively. The developed method was validated as per ICH guidelines for linearity, accuracy, precision, robustness and stability indicating studies and the method was successfully applied for the estimation of aliskiren and amlodipine in combined tablet dosage form.