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Asian Journal of Pharmaceutical Analysis
Year : 2019, Volume : 9, Issue : 3
First page : ( 133) Last page : ( 137)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2019.00025.5

Validation of Stability Indicating RP-HPLC, Method of Analysis for assay of Ivabradine HCl in SR Tablet

Mohite M. T.1, Dudhabale V. V.2,*, Chandgude K. V.2

1Department of Pharmaceutical Chemistry, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Maharashtra, India

2Department of Pharmaceutical Quality Assurance, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Maharashtra, India

*Corresponding Author E-mail: vaishududhabale1995@gmail.com

Online published on 31 December, 2019.

Abstract

A simple and precise method was developed for the assay of Ivabradine from SR tablet formulation. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method; Ivabradine shows the maximum absorbance at 286 nm. The separation was achieved on RP-HPLC Isocratic system equipped with HPLC Agilent 1100 series. The mobile phase was prepared with buffer pH 5.8: Acetonitrile: Methanol in the ratio of 65: 25: 10 o-phosphoric acid used for the pH adjustment (pH-5.8). The method was validated for accuracy, precision, linearity, Specificity, stressed studies, robustness, etc. Linearity was observed in the concentration range of 70–130%and gave mean correlation coefficient 0.999. The developed RP-HPLC method was found to be accurate, precise and was successful applied to a pharmaceutical tablet formulation for qualitative estimation of Ivabradine.

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Keywords

Ivabradine, RP-HPLC, Force degradation, method validation.

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