Two simple, selective, and accurate chromatographic techniques have been developed and validated for the estimation of Ivabradine hydrochloride in bulk and pharmaceutical dosage form. A high performance thin layer chromatography (HPTLC) and a reverse phase high performance liquid chromatography (RP-HPLC) were developed for ivabradine by optimizing various parameters. The HPTLC separation was carried out on aluminium sheet of pre-coated silica gel 60 F254 using Methanol: Diethyl ether: Cyclohexane: 10% triethyl amine in the ratio of (8:0.5:0.5:1%v/v/v/v) as mobile phase followed by analysis at 287nm. The RP-HPLC separation of ivabradine was performed on a LichroCart®250-4 column with a mobile phase consist of 45:55v/v of 5% Triethyl amine: methanol (buffer pH adjusted to 7 with ortho phosphoric acid) with the flow rate of 1ml/min and the detection at 286nm. The retention time for Ivaradine HCl was found to be 6.5min. The methods were validated with respect to linearity, precision, repeatability, LOD, LOQ, robustness and specificity. The linearity of the methods was found to be 200 to 1200ng/spot for HPTLC and 0.3-1.5μg/ml for RP-HPLC. The proposed methods were successfully applied for the determination of Ivabradine hydrochloride in bulk and tablet dosage form. The results were analyzed statistically found to be satisfactory.
