Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION ALISKIREN AND AMLODIPINE IN PHARMACEUTICAL DOSAGE FORMS

*Chandra Sekhar Kurimisetty, V. Surya Narayana Rao, Mastanaiah Thummisetty, Surender Babu Lagu

ABSTRACT

A new, simple, precise, rapid and accurate RP-HPLC (Reverse Phase – High Performance Liquid Chromatography) method has been developed for the simultaneous estimation of Aliskiren and Amlodipine in pharmaceutical dosage form. The chromatographic separation was achieved on Alliance Waters 2695 HPLC using INERTSIL ODS, 150 x 4.6 mm, 5.maintained at ambient temperature with mobile phase, Buffer: water: Acetonitrile (50:50), flow rate 1.0 ml/min, load volume 10 μl and a run time of 8 min. Buffer was prepared with Triethylamine and adjusted pH to 3.2 with Ortho-Phosphoric Acid. Linearity response was established over the concentration range of 50-150 μg/ml for Aliskiren and 5-15 μg/ml for Amlodipine. Method precision of Aliskerin and Amlodipine (%RSD) is found to be 0.61 & 0.369. LOD of Aliskiren and Amlodipine is found to 0.393 & 0.076, whereas LOQ is 1.193 & 0.232 for Aliskerin and Amlodipine respectively. Hence, the developed method can be successfully employed for routine quality control of Aliskiren and Amlodipine in drug testing laboratories and pharmaceutical industries.

Keywords: Aliskiren, Amlodipine, RP-HPLC, Beta Blockers.