Abstract
Background: The objective of this work was to develop and validate a rapid and effective high performance chromatographic method for the analysis of Ivabradine-HCl.
Introduction: A sensitive, precise, simple and robust high-performance liquid chromatographic method used for the analysis of Ivabradine-HCl (IBH) in mobile phase and rabbit plasma was established and validated as per ICH-guidelines. Method: The separation was performed on HSC18 (25 cm x 4.6 mm, 5µm), column with Acetonitrile: Buffer pH 6.0), 40:60 v/v) as mobile phase and a flow rate of 1.0 ml/min in the isocratic mode. IBH was detected at a wavelength of 287 nm. Result: A well-defined chromatographic peak of IBH was exhibited with a retention time of 4.062 minutes and tailing factor of 1.658.The linear regression analysis data for calibration plots showed good linear relationship with R=0.9998 in the concentration range of 1.56-100 µg/ml both in mobile phase and in plasma. Pantoprazole was used as internal standard (IS). The method was validated for precision, recovery and robustness. Intra and Inter-day precision (% relative standard deviation) were less than 2%. Conclusion: The method showed the mean recovery of 96% to 102% and RSD < 1% in Mobile phase and rabbit plasma. HPLC method was found to be highly precise, sensitive and accurate for the determination of IBH in pharmaceutical dosage form successfully applied to the commercial tablets without any interference of excipients.Keywords: Ivabradine-HCl, HPLC, validation, acetonitrile, plasma, mobile phase.
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