Development and Validation of Analytical Methods for the Identification in Canprophem - AK® Suppositories with the New Original Polyene Antibiotic.

Introduction: The paper presents analytical methods for the identification of Roseofungin active pharmaceutical ingredient (API) using thin layer chromatography (TLC) and spectrophotometry in the ultraviolet region, for the drug CANPROFEM - AK^® containing the original polyene antibiotic Roseofungin in the form of suppositories. The study established optimal conditions for the experiment, including sample preparation; the Specificity validation characteristic was examined for each method. Results: Method 1 employed the TLC plate pre-coated with a layer of F254 silica gel using n-butanol saturated with purified water as a mobile phase; the substance was identified in UV light at a wavelength of 365 nm. The method makes it possible to uniquely and specifically identify roseofungin in the presence of placebo components. In method 2, the maximum of the ultraviolet absorption spectrum of the solution being tested coincides with the maximum of the ultraviolet absorption spectrum of the reference sample solution (364±2 nm). Conclusion: The methods are suitable for solving the intended objectives and are included in the draft analytical normative document on the finished product quality control by the Identification characteristic. [ABSTRACT FROM AUTHOR]