Volume :
3
Issue :
1
Abstract :
A reverse phase high performance liquid chromatographic assay method has been developed and validated for simultaneous estimation of Hydrochlorothiazide, Amlodipine besylate and Telmisartan in tablet dosage form. Stationary phase was 150 mm x 4.6 mm, 5 μm C-18 column, from Novapak, mobile phase was degassed mixture of 50mM ammonium acetate buffer pH 4.5, and acetonitrile in the ratio of 65:35 and flow rate at 1.2 ml/min, at ambient condition with detector setting at 235nm. The retention times of Hydrochlorothiazide, Amlodipine and Telmisartan are 3.0 min, 4.0 min and 5.1 min respectively. Above method was validated as per ICH guidelines. Specificity was confirmed by comparing the placebo chromatogram with that of standard. Linearity of the method was achieved from 80% to 120% of test concentration. The precision of the method is carried out by six different test preparations and the % relative standard deviation was calculated. The accuracy of the method extracted in triplicate at three concentration levels, i.e. 50%, 100% and 150% of test concentration and recovery calculated. Robustness was performed by changing flow rate, mobile phase ratio. Above validated method can be recommended for simultaneous analysis of these drugs in tablets.