METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF AMLODIPINE AND CANDESARTAN BY REVERSE PHASE HPLC IN TABLET DOSAGE FORMS
M,Bindu, G.Kumaraswamy* ,N.Ravindra.
Department of pharmaceutical analysis, Chilkur Balaji College of Pharmacy, Aziz Nagar –Hyderabad. 500075, Telangana.
A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Amlodipine and Candesartan in tablets. The chromatographic separation was carried out on a Phenomenax Luna ODS analytical column (250×4.6 mm; 5 μm) with a mixture of acetonitrile: phosphate buffer pH 3 adjusted with orthophosphoric acid (80:20, v/v) as mobile phase; at a flow rate of 1.0 ml/min. UV detection was performed at 235 nm. The retention times were 2.526 and 5.526 min. for Amlodipine and Candesartan respectively. Calibration plots were linear (r2>0.998) over the concentration range 10-60 μg/ml for Amlodipine and 10-60 μg/ml Candesartan. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Amlodipine and Candesartan in bulk drug and tablet dosage form.