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Abstract

Development and validation of RP-HPLC method for the estimation of ivabradine hydrochloride in tablets

Author(s): Sunitha Seerapu, BP Srinivasan
Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India

Correspondence Address:
B P Srinivasan Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India E-mail: [email protected]


A simple, sensitive, precise and robust reverse-phase high-performance liquid chromatographic method for analysis of ivabradine hydrochloride in pharmaceutical formulations was developed and validated as per ICH guidelines. The separation was performed on SS Wakosil C18AR, 250Χ4.6 mm, 5 μm column with methanol:25 mM phosphate buffer (60:40 v/v), adjusted to pH 6.5 with orthophosphoric acid, added drop wise, as mobile phase. A well defined chromatographic peak of Ivabradine hydrochloride was exhibited with a retention time of 6.55±0.05 min and tailing factor of 1.14 at the flow rate of 0.8 ml/min and at ambient temperature, when monitored at 285 nm. The linear regression analysis data for calibration plots showed good linear relationship with R=0.9998 in the concentration range of 30-210 μg/ml. The method was validated for precision, recovery and robustness. Intra and Inter-day precision (% relative standard deviation) were always less than 2%. The method showed the mean % recovery of 99.00 and 98.55 % for Ivabrad and Inapure tablets, respectively. The proposed method has been successfully applied to the commercial tablets without any interference of excipients.

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