A Chromatographic Quality Control Procedure Based on HPLC for 5-Hydroxymethylfurfural in Autoclaved D-Glucose Infusion Fluids

Abstract

A specific quantitative chromatographic assay method is described for 5-hydroxymethylfurfuraldehyde (SHMF) in degraded D-glucose solutions incorporating an internal standard. Comparison is made between the chromatographic method and the official direct ultraviolet absorption measurements at 284nm for solutions of D-glucose degraded to different extents. Hospital samples of autoclaved Dextiose Injection, 5% w/v, are also examined by both methods and it is demonstrated that quite different results can be obtained depending upon the conditions af measurement. It is demonstrated that the direct absorption method does not provide an adequate limit test for compounds related to 5HMF. An hplc study of the initial stages of dextrose decomposition in neutral solution.Journal ofPharmocyand PharmacoloD, 30, 510-511. 6 . Tahir, A.M. & Cates, D.M. (1974) A spectrophotomeuic investigation of the yellow colour that accompanies the formation of furan derivatives in degraded sugar solutions. Curbohydrarc Research, 34, 249 -262.

HPLC Studies on the Degradation Profiles of Glucose 5% Solutions Subjected to Heat Sterilization in a Microprocessor-Controlled Autoclave

“…Because 5-HMF was used to monitor degradation in glucose samples, a sensitive and accurate assay was required. A reversed-phase HPLC method was developed from published methods (6,7) with some modification. An organic modifier, methanol, was included in the buffered mobile phase, to shorten the retention times and improve column efficiency.…”

“…It has been suggested that the recommended U.V. method will also measure intermediates (7) and is to that extent unselective. Using the major absorptivity value of 1316 at 283 nm determined by Taylor (7, S), this would give an equivalent maximum concentration of 23.8 pg/ml of 5-HMF, if the absorbance was due solely to 5-HMF.…”

Factors Generating Glucose Degradation Products In Sterile Glucose Solutions For Infusion: Statistical Relevance Determination Of Their Impacts

“…glycosylated haemoglobin) 13 . Among the GDPs cited above, 5-HMF and 2-FA are considered as important indicators of degradation 14 , 15 and, according to Linden et al . 3 and Thornalley et al .…”

Assay of Lignocaine in Laevulose Infusion by Second Derivative Uv Spectroscopy

“…Lignocaine hydrochloride 0.3% w/v and laevulose 5% w/v produced as a 500 ml infusion is sterilized by autoclaving at 115-1 18°C for 30 min. Laevulose partially degrades on autoclaving to 5-HMF and related substacces (1,2), which have been reported as a cause of infusion thrombophlebitis (3).…”