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Abstract

NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IVABRADINE HYDROCHLORIDE (ANTIANGINAL) DRUG

Suresh Kumar Yadav*, Dr. C. Sreedhar, T. Sreenivasa Rao, Akkamma H. G.

ABSTRACT

Chromatography was performed by isocratic reverse phase separation using a Agilent Eclipse Plus C8 column of particle size 5μ, (150×4.6mm). The separations were achieved at the UV detection at 281nm using the mobile phase of Tris buffer: Acetonitrile in the ratio of 25:75. Flow rate was 1ml/min and the injection volume was set at 20 μl with 10mins of runtime. The retention time was observed at 5.13 mins for Ivabradine Hydrochloride. The method was validated by using various validation parameters like accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ). The standard curve was linear over a working range of 10-60 μg/ml and gave an average correlation factor 0.9936 for Ivabradine Hydrochloride. The limit of detection and the limit of quantification were found to be 1.07 μg/ml and 3.57 μg/ml for Ivabradine hydrochloride respectively. The method showed good recoveries and relative standard deviations of
intra and inter day assay less than 2. This method can be easily and conveniently used for routine analysis of Ivabradine Hydrochloride in bulk and tablet dosage forms.

Keywords: Ivabradine Hydrochloride, RP-HPLC, Accuracy, Precision, Linearity, LOD, LOQ.


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