Method of determination of the — purity of the dihydrochloride of manidipine multiforme.

摘要

It describes a method for determining the purity multiforme of the dihydrochloride of manidipine multiforme beta in a pharmaceutical tablet using spectral information, comprising the steps consisting in: i) preparing a series of samples, each of the samples are known comprising an amount of multiforme beta, and a quantity of alpha polymorphic, in which, in each of the samples are known, the total amount of compounds remains the same, while their ratio is modified; ii) acquire the raman spectra of the various known samples; iii) to select one or more signals of wavelengths for each shape so that the spectral differences which appear in each of the known samples are essentially appreciable and so that the signals of the excipients do not interfere, iv) to carry out a statistical analysis of the spectral data of the series of samples which are known; v) to collect the spectral data of a sample comprising the dihydrochloride of manidipine multiforme beta with a purity multiforme unknown; etvi) calculate the purity multiforme the polymorphic beta.