Development of the method for quantitive determination of an active substance in “Tamsuloprost” suppositories

V. I. Grytsenko, O. A. Ruban, S. M. Gubar, V. I. Gusarov


Prostatic hyperplasia is one of the most common diseases among elderly men. An integral condition for appearance and development of benign prostatic hyperplasia is the poor state of androgen production in men. An urgent task for the contemporary pharmaceutical science is to create new effective medicines. The prominent place in the treatment of prostate diseases is occupied by alpha-adrenoblockers, which are drugs of the first-line treatment, such as Tamsulosin hydrochloride being a selective and competitive blocker of postsynaptic α1A-adrenergic receptors. Selectivity of Tamsulosin to α1A-adrenergic receptors located in the bladder is several times greater than its ability to interact with α1B-adrenoceptors that are located in the vascular smooth muscles. Therefore, the use of Tamsulosin in the treatment of prostate dseases does not affect the patients blood pressure. The aim of the work was to develop the method for quantitative determination of the active substance Tamsulosin hydrochloride in “Tamsuloprost” suppositories for the treatment of prostatic hyperplasia. Development of the assay method was performed on a Specord 200 spectrophotometer (Analytik Jena, Germany) and a ProStar analytical chromatograph (Varian, USA). The authors have suggested the method for quantitative determination of the active substance Tamsulosin hydrochloride in “Tamsuloprost” suppositories for the treatment of prostatic hyperplasia. During the experiment it has been proven that it is unreasonable to use the method of spectrophotometry in the UV-region to control the content of Tamsulosin in suppositories because of the overlap of two analytical wavelengths of Tamsulosin by the maxima of placebo components. The possibility of using a more specific method – high performance liquid chromatography (HPLC) has been proven and the conditions under which there is a complete separation of placebo components and the active substance within the time taken have been proposed.


suppositories; quantitative determination; high performance liquid chromatography (HPLC); Tamsulosin hydrochloride

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