DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF IVABRADINE AND METOPROLOL IN PHARMACEUTICAL DOSAGE FORM AND IN BLOOD PLASMA Authors: Kumar D , PANDA SK, SAHOO SK AND MANDAL SK
ABSTRACT
A simple reverse phase HPLC method was developed for the simultaneous estimation of Ivabradine and Metoprolo in bulk and tablet form. Chromatography was performed by isocratic reverse phase separation on a stainless steel column 4.6 x 150mm, symmetry column packed with octa decyl silane bonded to porous silica (C18) with particle size 5 micron with mobile phase containing Methanol and phosphate buffer in the ratio of 50:50. The flow rate was 0.8 ml/ min and effluent was monitored at 260 nm. The retention times were 2.24 min and 2.66 min Metoprolol and Ivabradine respectively. The standard curve was linear over a working range of 25–150 µg/ml for Metoprolol and 5-30 µg/ml for Ivabradine and gave an average correlation coefficient of 0.999, and 0.999 for Metoprolol and Ivabradine respectively. The limit of quantitation (LOQ) of this method was 0.56 µg/ml and 3.8 µg/ml for Metoprolol and Ivabradine respectively. The absolute recovery was 99.96% for Metoprolol and 99.86 for Ivabradin. Degradation products produced as a result of stress studies did not interfere with the detection of Metoprolol and Ivabradine, the assay can thus be considered stability-indicating.
Keywords: Metoprolol, Ivabradine, RP-HPLC, Phosphate Buffer, Methanol, Validation
Publication date: 01/05/21 https://ijbpas.com/pdf/2021/May/MS_IJBPAS_2021_5489.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.5.5489