Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CHLORTHALIDONE HYDROCHLORIDE, AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL IN BULK AND COMBINED TABLETS DOSAGE FORMS

Shweta Hingde* and Dr. Snehalatha Boddu

Abstract

A simple, selective, accurate high Performance Liquid Chromatographic (HPLC) method was developed and validated for the analysis of Chlorthalidone HCl, Amlodipine Besylate, and Olmesartan Medoxomil. The separation was achieved using Prontosil C18 column (250 x 4.6 mm, 5μm) and mobile phase consisting Buffer and Acetonitrile in the ratio 40: 60 with pH adjusted to 3.0 with orthophosphoric acid at flow rate of 1 ml/min. The retention time of Chlorthalidone HCl, Amlodipine Besylate and Olmesartan Medoxomil was found to be 3.017 mins, 3.313 mins and 5.010 mins respectively. The calibration curve were linear over the concentration ranges 26.75- 38 μg/ml, 7.5-20 μg/ml and 30-80 μg/ml for Chlorthalidone HCl, Amlodipine Besylate, Olmesartan Medoxomil respectively. The proposed method is accurate with 99% recovery for Chlorthalidone Hydrochloride, 100.20% for Amlodipine Besylate and 98.97% recovery for Olmesartan Medoxomil in pharmaceutical preparation were all greater than 98% and their relative standard deviations were not more than 2.0%. Therefore, proposed method can be used as a more convenient and efficient option for the analysis of all drugs in bulk and tablet dosage form.

Keywords: Chlorthalidone Hydrochloride, Amlodipine Besylate, Olmesartan Medoxomil, RP-HPLC, Validation.