Method for HPBCD analysis in pharmaceutical formulations

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Hydroxypropyl-β-cyclodextrin is added to pharmaceuticals, including vaccines, to improve the solubility in water, stabilizing, etc. It is also expected to be used as adjuvant of vaccines in recent years. In this application published by Shodex, trypsin inhibitor and hydroxypropyl-β-cyclodextrin were separated using OHpak SB-802.5 HQ​. It is possible to measure and quantify hydroxypropyl-β-cyclodextrin without deproteinization by using a column for SEC. The calibration curve shows good linearity in the range from 0.05 to 10mg/mL. 

Sample : 1mg/mL each, 50µL 1. Trypsin Inhibitor (MW: 20,000) 2. HPBCD
Columns : Shodex OHpak SB-802.5 HQ (8.0mmI.D. x 300mm) x 2 Eluent : **PBS(-)/CH3CN=80/20 Flow rate : 1.0mL/min Detector : Shodex RI Column temp. : 30°C **PBS(-) Phosphate buffered saline without calcium and magnesium


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