Abstract

This paper provides a review of the pharmacopoeial methods for determination of the content of glucose in parenteral solutions (HPLC/RID method, polarimetry and volumetric titration) and evaluation of all critical aspects of the proposed methods, with a focus on accuracy, precision, time of analysis and resources for introducing, maintenance and conducting analysis. Comparative analysis of the results from assay (ten independent determinations) of Glucose 5% w/v solution for intravenous infusion, obtained using all three methods, was performed. The analysis confirmed that there is no statistical difference between the testing results obtained with each method, indicating that all three methods provide valid accurate and precise results. However, the availability of the equipment and trained personnel may be the crucial factor for small laboratories for selection of the method for assay of glucose in parenteral preparations. The obtained results and discussion on all critical aspects (accuracy, precision, time of analysis and resources for introducing, maintenance and conducting analysis) of the proposed methods, provide a valuable input to small laboratories on the suitability of these methods for quality control of Glucose 5% w/v solution for intravenous infusion. Keywords: Glucose, HPLC/RID, Polarimetry, Volumetry

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