Abstract

METHOD DEVELOPMENT FOR THE ANALYSIS OF COMBINE PRODUCT OF AMLODIPINE BESILATE AND ROSUVASTATIN CALCIUM IN PHARMACEUTICAL DOSAGE FORM

Dr. Praveen Kumar Ashok, Mr. Saurabh Pant, Mr. Sonu and Mandeep Limbu*

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Abstract

Triple layered tablet having various excipients and a new combination of APIs i.e. amlodipine besylate, rosuvastatin calcium and hydrochlorothiazide was prepared through wet granulation. The concentration of disintegrant and diluent was kept different in formulations of all APIs. At compression stage, nine different formulations from H1 to H9 having different combinations were prepared. Layers T1, T2 and T3 of all the three APIs had disintegrant concentration of 3%, 5% and 7 % respectively. In vitro analysis of granules was made by determining angle of repose, losson drying, bulk density, tapped density, hausner ratio. Results of all these parameters were quite similar in all layers, whichshowed that change in disintegrant concentration does not affect the flow ability of granules to much extent. After compression, tablets were further subjected to weight variation, hardness, thickness, friability, disintegration, dissolution studies and FTIR. In vitro drug release data of all formulations were studied which showed that all the formulations exhibitedzero order release. Results indicated that H8 had the best results in terms of physicochemical properties, assay and dissolution studies. The external morphology of formulations were further analyzed using scanning electron microscopy and differentialscanning calorimetry. Triple layered tablet was successfully developed and characterized.

Keywords: Amlodipine besylate, rosuvastatin calcium and hydrochlorothiazide, FTIR, scanning electron microscopy anddifferential scanning calorimetry.