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Development and Validation of RP-HPLC Method for the Estimation of Ivabradine Hydrochloride in Tablets.

Seerapu S, Srinivasan BP - Indian J Pharm Sci (2010)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), Goverment of N. C. T. of Delhi, M. B. Road, Pushp Vihar, Sector-3, New Delhi-110 017, India.

ABSTRACT
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, 250×4.6 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.

No MeSH data available.


Related in: MedlinePlus

Chromatogram of ivabradine hydrochloride
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Figure 1: Chromatogram of ivabradine hydrochloride

Mentions: To achieve sharp peak under isocratic conditions, mixtures of methanol and phosphate buffer in different combinations were tried as mobile phase on a C18stationary phase. A binary mixture of methanol and phosphate buffer (pH 6.5) in 60:40 v/v proportions was proved to be the most suitable of all combinations since chromatographic peak was better defined and free from tailing with this system. Under the above-mentioned chromatographic conditions, the retention time of 6.55±0.05 min (fig. 1) was obtained for ivabradine hydrochloride.


Development and Validation of RP-HPLC Method for the Estimation of Ivabradine Hydrochloride in Tablets.

Seerapu S, Srinivasan BP - Indian J Pharm Sci (2010)

Chromatogram of ivabradine hydrochloride
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3116321&req=5

Figure 1: Chromatogram of ivabradine hydrochloride
Mentions: To achieve sharp peak under isocratic conditions, mixtures of methanol and phosphate buffer in different combinations were tried as mobile phase on a C18stationary phase. A binary mixture of methanol and phosphate buffer (pH 6.5) in 60:40 v/v proportions was proved to be the most suitable of all combinations since chromatographic peak was better defined and free from tailing with this system. Under the above-mentioned chromatographic conditions, the retention time of 6.55±0.05 min (fig. 1) was obtained for ivabradine hydrochloride.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), Goverment of N. C. T. of Delhi, M. B. Road, Pushp Vihar, Sector-3, New Delhi-110 017, India.

ABSTRACT
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, 250×4.6 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.

No MeSH data available.


Related in: MedlinePlus