Analytical Method Development and Validation for the Determination of Ivabradine HCl by RP-HPLC in bulk and Pharmaceutical Dosage form
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A simple, rapid, highly sensitive, selective, specific, robust RP-HPLC method has been developed and validated for the estimation of Ivabradine HCL in bulk and pharmaceutical dosage form.
The Chromatographic separation was obtained using a mobile phase Methanol: ACN (80: 20 v/v) on Zorbax EclipsPlus C18 (250mm×46mm, 5.0μ) at 30℃ with UV detection 286 nm at flow rate 1ml/min. The linearity was found to be 2.5–50μg/ml. The retention time was found to be 5.8 min.
The method was validated according to ICH. The correlation coefficient (r2) of HPLC method was found to be 0.9998. The LOD and LOQ were found to be 0.0216μg/ml and 0.06537μg/ml respectively. The intra-day and inter-day precision and accuracy values for method were found to be ˃2% RSD.
The ProposedRP-HPLC method has been successfully applied to the commercial tablets without any interference of excipients. The method can be used for the routine analysis in industry forIvabradine HCLin bulk and tablet dosage forms.
Ivabradine HCL, RP-HPLC, Pharmaceutical Dosage forms, Mobile Phase, ICH, Validation.