Method Of Polarographic Determination Of Platyphylline In A Form Of N-Oxide And Its Validation In Solution For Injection

Abstract

A new approach was studied for determination of alkaloid Platyphylline in a form of N-oxide by reduction current on the dropping mercury electrode. The optimal conditions were selected for chemical transformation (using of potassium peroxymonosulfate) of Platyphylline into N-oxide and with following product reduction on the electrode. On this basis, the methods of determination of Platyphylline in the solution for injections and in tablets were developed. New methods of indication are characterized by very simple sample preparation, wide linear range, low limit of determination (2.1∙10-6 mol∙L–1), sufficient accuracy and selectivity. These methods were checked while analysing one-component solution for injections and combined drug – tablets. The obtained results of analysis were compared to those indicated in the certificate of analysis issued by testing laboratories of the State Service of Ukraine on Medicines and Drugs Control. Defined metrics vary from 97.17 to 102.02 %. The method of determination Platyphylline in the solution for injections «Platyphylline-Zdorovye» is validated (the criterion linearity, accuracy as well as precision). The validation evaluation results have proved the correctness and reliability of the developed method. The main feature of the proposed method for the determination of Platyphylline using N-oxide as an analytical form is the ability to determine directly the metabolite of Platyhylline. Consequently, the work can be adapted for the determination of N-oxide Platyphylline in plant materials.