Certified Reference Material for Quantitative Evaluation of Carbohydrate Stabilizers by Ion Exchange HPLC

Quantitative determination of excipients is a pharmacopoeial requirement for assessing the quality of biological medicinal products. For determination of carbohydrate stabilizers (sorbitol, mannitol, trehalose, glucose, lactose, sucrose, and maltose), the Scientific Center for Expert Evaluation of Medical Products of the Ministry of Health of the Russian Federations prescribes the method of anionic exchange HPLC with pulse amperometric detection. Routine application of this method requires a reference material of in tralaboratory analytical control, since the suitability of chromatographic systems must be checked prior to use of all chromatographic methods for quality control of pharmaceutical substances and medicinal prod ucts. In addition, certified reference materials permit interlaboratory comparison of test results. In this study, we set out to develop the composition and a release form of a certified reference material for stability con trol of determination of carbohydrate stabilizers. The range of the resolution factor between the peak pairs of sorbitol/mannitol and mannitol/trehalose was used as a certified characteristic, being1.8–2.4 and 2.1–2.9, respectively. For other peak pairs (trehalose/glucose, glucose/lactose, lactose/sucrose, and sucrose/maltose), a semi-quantitative certified characteristic was assigned, i.e., a resolution factor of at least 3.0.