Development of Analytical Procedures for Quantification of Psorantron C®

Abstract

Background: Psorantron C® is an ointment containing dithranol (1,8-dihydroxy-9-anthrone) and salicylic acid as active ingredients, and it stops the uncontrolled division of cells in tissues affected by psoriasis. It is an original medication developed at the Tbilisi State Medical University (TSMU) I. Kutateladze Institute of Pharmacochemistry. The primary active ingredient in the ointment is dithranol. The salicylic acid determines keratolytic properties, which improves the therapeutic effect of the drug. Dithranol and salicylic acid were selected as chemical and biological markers for the development of a method for quantification of the ointment. Objectives: This study aimed to develop a new method for quantifying the ointment Psorantron C®, developed at the Tbilisi State Medical University (TSMU) Iovel Kutateladze Institute of Pharmacochemistry. Methods: High-performance liquid chromatography (HPLC) separation was performed on an Eclipse plus C-18 column (250mm x 4.6mm, 5µm) with a solvent system of acetonitrile-water (60:40) under isocratic conditions, and UV detection was performed at 254 nm and 354 nm. Results: The dependence of the concentration of solutions on the peak area is linear R²=0.999. Method Standard Deviation (SD)≤1% and Relative Standard Deviation (RSD) ≤1.5%. Conclusions: The method provided is accurate, sensitive, and reproducible, which can be successfully used for the quantification of Psorantrone C® ointment.