Abstract
Objectives: To study 5-hydroxymethylfurfural (5-HMF) spectral characteristics aiming at their future application in analytical procedures and their validation for the determination of 5-HMF in liquid products containing glucose after sterilization.Method: Direct spectrophotometric method for the determination of 5-HMF using the molar absorption coefficient at the absorption maximum (284 nm).Results and discussion: aqueous 5-HMF solutions have strong absorption in the ultraviolet range below 310 nm and give two absorption maxima at wavelengths of 229–230 nm and 284 nm. An excellent linear relationship between absorbance and 5-HMF concentration was observed in the concentration range of 2.0–10.0 mg/l. The linear dependence passes through the origin. The molar absorption coefficients of 5-HMF were determined and found to be 3007 mol−1•L•cm−1at 229–230 nm and 16070 mol−1•L•cm−1at 284 nm. The use of the molar absorption coefficient of 5-HMF stated in the Pharmacopeia of the United States of America for determining 5-HMF in polydextrose (16830 mol−1·L·cm−1at 283 nm) gives recovery results for model solutions of reference substance of 5-HMF that are acceptable from the point of view of the requirements of the State Pharmacopeia of Ukraine for methods of quantitative determination of impurities. However, other values of the molar absorption coefficient (17000 and 22700 mol−1•L•cm−1) given in the scientific publications are unsuitable for the quantitative determination of 5-HMF as an impurity in medicinal products.Conclusion: The molar absorption coefficient (16830 mol−1•L•cm−1at 284 nm) may be used to quantify 5-HMF as an impurity in medicinal products containing glucose. For a specific medicinal product, a full validation of the analytical procedure of the 5-HMF determination is required taking into account the composition of this product.
Highlights
IntroductionHeat sterilization is widely applied to medicinal products in liquid dosage forms
In the pharmaceutical industry, heat sterilization is widely applied to medicinal products in liquid dosage forms
It was shown in a published paper (Hudz et al 2018) that 5-HMF solutions has a strong absorption in the ultraviolet range below 310 nm and had two absorption maxima at the wavelengths of 229–230 nm and 284 nm (Fig. 1)
Summary
Heat sterilization is widely applied to medicinal products in liquid dosage forms. Colour and 5-HMF contents are important quality indexes in sterilized liquid medicinal products which contain glucose as an active pharmaceutical ingredient (Kjellstrand et al 2004; Hudz et al 2018; BP 2009). Among such medicinal products are solutions for infusions and peritoneal dialysis. It should be noted that 5-HMF is a very important quality index for food products as well (Zappalaet al. 2005)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
