ANALYTICAL METHOD VALIDATION OF RP-HPLC FOR THE ESTIMATION OF ATENOLOL AND AMLODIPINE BESYLATE IN BULK AND TABLET DOSAGE FORMS

The chromatographic separation was Analytical method Development and validation plays an important role in the discovery, Development and manufacture of pharmaceuticals. The methods used ensure the identity, purity, potency, and performance of drug products. There are many factors to consider when developing methods. The majority of the analytical development effort goes into validating a stability indicating HPLC Method. The goal of the HPLC Method is try and separate quantify the main active drugs, any reaction impurities, all available synthetic intermediates and degradants. 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 tablet formulations. The chromatographic separation was achieved on Water's 717 Plus Autosampler HPLC using octadecysilane bonded C 18 , 5 µm, 250 cm x 4.6 mm column maintained at ambient temperature with mobile phase, Buffer: Acetonitrile: Methanol, Mobile phase-mix volume of acetonitrile 45 volume or methanole 35 volume a 5 ml Tetrabutyl ammonium hydroxide in 1000 ml with makeup HPLC water of a mixture 20 volume, flow rate 1.5 ml/min, load volume 2 l and a run time of 1 min he detection was performed at 225 nm. Buffer was prepared with Tetrabutyl ammonium hydroxide and adjusted pH to 3.0 with Ortho-Phosphoric Acid.