ASSESSING THE SUITABILITY OF THE METHOD FOR THE QUANTITATIVE DETERMINATION OF SODIUM HYALURONATE IN MEDICAL DEVICES OF INJECTABLE IMPLANTS
DOI:
https://doi.org/10.32782/health-2024.2.15Keywords:
validation, analytical technique, quantitative definition, hyaluronic acid, sodium hyaluronate, medical products.Abstract
One of the most common and most popular medical device are injectable implants based on hyaluronic acid. Such prevalence is due to a wide range of properties of sodium hyaluronate, which have found their application in many fields of medicine, such as cosmetology, ophthalmology, surgery, dermatology, etc. Given that the above-mentioned products are medical devices of the highest risk class, it is critically necessary for each manufacturer to conduct quality control of finished products according to defined quality characteristics. One of the key characteristics of the quality of a medical device is the quantitative content of sodium hyaluronate as the main component, which depends on the effectiveness of the product. To control the quantitative content of sodium hyaluronate, the method described in the European Pharmacopoeia for the substance sodium hyaluronate was chosen. This article demonstrates the process of validation of the method of quantitative determination of sodium hyaluronate by the method of absorption spectrophotometry in the ultraviolet region in the line of medical devices for injectable implants based on un-crosslinked hyaluronic acid 1.1%, 18%, 2.2%, 2.5%, 3,3%. The purpose of the validation is to confirm the possibility of using this technique to determine sodium hyaluronate in the gel of the injectable implant, which contains a number of auxiliary substances. The authors present the obtained experimental data, validity criteria and statistical calculations that demonstrate the validity of the technique in the studied conditions and the possibility of its use for the determination of sodium hyaluronate in the finished medical device.
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