Studies On Quality Standard Of Ivabradine Hydrochloride

This thesis studied the quality standard of Ivabradine hydrochloride. We studied the shape and properties, such as the appearance, solubility, hygroscopicity and specific rotation. The test results showed that Ivabradine hydrochloride was white or almost white powder, it was odorless and extremely lead wet. Ivabradine hydrochloride can be dissolved in water, methanol or dimethyl sulfoxide, and slightly soluble in ethanol and acetone. Its specific rotation is+6.0°+8.0°.We also had the identifying experiments of Ivabradine hydrochloride. It was absorbed maximum in 285nm wavelengths by MV-VIS spectrophotometry. Its pH value was 5.0-6.5, and its auqeous solution was clarify and colorless. The determining of related substances showed that the area of each impurity peak and not more than the peak area of reference solution (1.0%). Its infra-red reference spectra was corresponding to reference spectrum. The impurity peaks of isomers were not greater than the peak area of reference solution (0.5%). The detection of residual solvents showed that dichloromethane and acetonitrile were both up to specification. After the products were dried at 105℃, its loss on drying was no more than 1.0%. The residues after residue on ignition were no more than 0.1％. This product contains no more than 10 PPM Pb. We used high performance liquid chromatography to determine the content of Ivabradine hydrochloride. The major peak's retention time of sample solution should correspond with that of the working standard solution. The identification of chloride in its aqueoμssolution was up to specification.We also made a study of the long-term stability data, and came to a conclusion that Ivabradine hydrochloride should preserve by sealing it airtight and the validity date was 24 months.