RESEARCH ON THE DEVELOPMENT OF DETERMINATION METHODS BIOLOGICALLY ACTIVE SUBSTANCES IN TRANSDERMAL ANTI-INFLAMMATORY PATCHES
DOI:
https://doi.org/10.11603/mcch.2410-681X.2023.i4.14376Keywords:
transdermal patch, identification, quantification, validation characteristicsAbstract
Introduction. Transdermal drug delivery systems are one of the innovative dosage forms, the use of which allows overcoming the associated disadvantages of other delivery methods. Oral dosage forms have significant disadvantages in terms of bioavailability, particularly due to first-pass hepatic metabolism. The development of transdermal drug delivery systems that improve the therapeutic effectiveness and safety of drugs in certain areas of the body, thus reducing both the size and number of doses, is relevant. Absorption of the drug occurs through the skin, which is an effective medium from which the active substance enters the systemic circulation for a certain time.
The aim of the study – to conduct experimental studies on the development of methods of identification and determination of the quantitative content of active pharmaceutical ingredients in a transdermal patch.
Research Methods. The objects of the study were model samples of the transdermal patch, the spectrophotometric method and the thin-layer chromatography (TLC) method.
Results and Discussion. The thin-layer chromatography method, in comparison with marker substances, proved the presence in the patch of salicylate derivatives, mostly similar in structure to salicin, flavonoid substances similar in structure to quercetin, luteolin, and rutin, and polyphenolic acids similar to chlorogenic acid. Quantitative content of substances of flavonoid nature in plant dry extracts of white willow bark and sage leaves was determined by the spectrophotometric method after preliminary extraction from the patch with water at a wavelength of 396 nm, in terms of luteolin (at least 0.25 mg per 1 cm2 of the patch). Such validation characteristics as linearity, precision, correctness and robustness were studied, which allow us to draw a conclusion about the correctness of the developed spectrophotometric technique (using acceptance criteria for content tolerances of +5.0 %). A high correlation coefficient (0.9998>0.9981) testifies to the linearity of the method over the entire concentration range of 80‒120 %.
Conclusions. Methods of identification and quantitative content of the main biologically active substances in the transdermal patch have been developed.
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