DEVELOPMENT OF THE MANGIFERIN IDENTIFICATION AND QUANTITATIVE DEFINITION METHODS IN SOFT MEDICAL FORM

Abstract

The aim of the work is development of methods of identification and quantitative determination of API in the composition of the antiherpetic gel.

Materials and Methods. The objects of the study are gel samples with mangiferin. To identify mangiferin, the TLC method with TLC plates with a layer of silica gel, fluorescent indicator F₂₅₄ and mangiferin standard sample was used. Quantitative determination was carried out by absorption spectrophotometry. Spectrophotometer "Evolution 60s" (Thermo Fisher Scientific, USA), analytical balances "AXIS" (Poland), measuring vessels of class A, and reagents according to the requirements of the SPhU were used.

Results and Discussion. Mangephyrin was identified by the TLC method after extraction from the gel with 70% alcohol in comparison with standard sample of mangiferin using a mobile phase - a mixture of solvents n-butanol : acetic acid : water (80 : 20 : 10), detected in UV-light at a wavelength of 254 nm. It was established that the sequence of zones of the comparison solution and the tested solution coincide. Quantitative determination of mangiferin was carried out by absorption spectrophotometry in 70% ethanol at a wavelength of 373 nm. It has been proven that the subordination of mangephyrin solutions at a wavelength of 373 nm to the Bouguer-Lambert-Bere law is observed within the concentration range from 0.002 mg/ml to 0.020 mg/ml. The calculated predicted total uncertainty of the results of the method, which is 1.21% £ 1.60%, indicates the correctness of conducting tests in another laboratory. When studying the validation characteristics of the method, it was established that the method is robust (Δt ≤ δmax = 0.51%, the tested solution and the comparison solution are stable for at least 1 hour), specific (d 0.18% £ 0.51%); linear (r 0.9999 ≥ min r 0.9981); precise (D% = 0.48 % ≤ 1.60 %) and correct (the criterion of practical insignificance of a systematic error of 0.03 %) is met.

Conclusions. TLC method is proposed for identification of mangiferin in gel.

For the quantitative determination of mangiferin, a method of absorption spectrophotometry in 70% ethanol at a wavelength of 373 nm was developed. It has been proven that the developed method is correct and can be used in the analysis of mangiferin in gel according to such validation characteristics as linearity, precision, correctness, robustness and specificity.