RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ATENOLOL AND AMLODIPINE BESYLATE IN PHARMACEUTICAL DOSAGE FORMS

A new, simple, precise, rapid and accurate RP-HPLC (Reverse Phase – High Performance Liquid Chromatography) method has been developed for the simultaneous estimation of Atenolol (AT) and Amlodipine Besylate (AB) in bulk and in tablet formulations. The chromatographic separation was achieved on Agilent technologies 1200 series HPLC using Inertsil C₁₈, 5 mm, 250 mm x 4.6 mm column maintained at ambient temperature with mobile phase, Buffer: Acetonitrile: Methanol (4:3.5:2.5 v/v/v), flow rate 1.0 ml/min, load volume 10 μl and a run time of 10 min. The UV detection was performed at 225 nm. Buffer was prepared with Triethylamine and adjusted pH to 3.0 with Ortho-Phosphoric Acid. The retention time and mean recoveries obtained for AT was 2.23 min and 100.1%, for AB was 5.97 min and 100.4% respectively. Linearity response was established over the concentration range of 50-150 μg/ml for AT and 5-15 μg/ml for AB. The correlation coefficient for AT and AB was 0.9992 and 0.9998 respectively. The recovery studies ascertained the accuracy of proposed method and the results were validated as per ICH guidelines. This novel method can be used for the routine quality control of both drugs in combination in tablet dosage form