The study to develop the methods of analysis and arrange quality rates of noopept substance for injectionable dosage forms

Noopept is a novel nootropic drug developed at the State Zakusov Institute of pharmacology, Russian academy of medical sciences.

The objectives of the present investigation were to study physical and chemical properties, to elaborate the techniques of analysis and to arrange quality rates of noopept, the substance for injectionable dosage forms.

The physical and chemical properties, the IR-, UV- and NMR- spectral characteristics were determined; the basic quality tests of the substance, such as solubility, melting point, appearance of solution, pH of solution, loss on drying, specific optical rotation, were conducted.

The determination of related substances and assay were carried out using high performance liquid chromatography technique with the standard reference sample of noopept. The tests were performed on a stainless steel column packed with octadecylsilyl silica gel (5 μm), as mobile phase a mixture of 500 volumes of water, 500 volumes of acetonitrile and 1 volume of glacial acetic acid was used, the detection wavelength - 205 nm.

Investigation on the stability of noopept substance was performed using short-term aging method. The shelf-life of noopept was estimated at two years.