Sorbitol is a sugar alcohol commonly used as a sweetener and stabilizer in a wide range of pharmaceutical formulations. This application shows a method of control of sorbitol according to Ph. Eur. Monograph 07/2019:0436. Astra® Sugar Ca(S) column provides a perfect resolution factor and peak symmetry under the conditions of the pharmacopoeial method.
ABSTRACT
HPLC-RID control of sorbitol according to Ph. Eur. Monograph 07/2019:0436 on an ASTRA® Sugar Ca(S) 9 µm column, 300 mm × 8.0 mm, part number AST-5906-WN80. Mobile phase 100% H2O, isocratic elution, column temperature 80 °C, injection volume 20 µL, refractive index detection (RID) at 55 °C. The method is run at two flow rates, 0.5 mL/min and 0.75 mL/min. Analytes and CAS numbers as printed: 1. mannitol, CAS number 87-78-5, 2. sorbitol, CAS number 50-70-4. The note shows four chromatograms on the ASTRA® Sugar Ca(S) column — the test solution at 0.5 mL/min (sorbitol at about 26 min) and at 0.75 mL/min (sorbitol at about 16 min), where mannitol is essentially absent, and reference solution (b) at both flow rates, where mannitol (peak 1) and sorbitol (peak 2) are baseline-resolved …
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MannitolCAS number 87-78-5
SorbitolCAS number 50-70-4
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