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Assay of Polyethylene Glycol 3350 for Oral Solution According to USP-NF Method (SB-802.5 HQ)

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According to USP40-NF35 method, the assay of polyethylene glycol 3350 in "Polyethylene Glycol 3350 and Electrolytes for Oral Solution" monograph should be analyzed using a column packed with L25. It is necessary for the system suitability to satisfy relative standard deviation (RSD) of ≤ 1.5%. It was confirmed that RSD was lower than 1.0% when polyethylene glycol 3350 was analyzed using OHpak SB-802.5 HQ.


Sample : 20 μL
1. Polyethylene glycol 3350
0.72 mg/mL


Columns      : Shodex OHpak SB-G 6B (6.0 mm I.D. x 50 mm) 
               + SB-802.5 HQ (8.0 mm I.D. x 300 mm)
Eluent       : 14 mg/L NaCl, 7.2 mg/L KCl, 16 mg/L NaHCO3, 54.8 mg/L Na2SO4
               and 35.2 mg/L NH4Br in H2O
               (dilute 40.0 mL of *Salt solution with H2O to 1000 mL)
Flow rate    : 1.0 mL/min
Detector     : Shodex RI
Column temp. : Ambient 

*Salt solution ; 0.35 mg/mL NaCl, 0.18 mg/mL KCl, 0.4 mg/mL NaHCO3, 1.37 mg/mL Na2SO4
                 and 0.88 mg/mL NH4Br in H2O

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