Analysis of Povidone According to Pharmacopeia Method (KC-811)

According to the United States Pharmacopeia and the National Formulary (USP43-NF38*), the European Pharmacopoeia (EP 10.4*), and the Japanese Pharmacopoeia (JP XVII*), analysis of formic acid for "Povidone", should be carried out with a column filled with strong acidic ion-exchange resin (USP-NF L17). The RSpak KC-811, a column filled with L17 packing material, confirmed the requirements were met. Using the same condition, we analyzed povidone K-30. The elution of formic acid was observed by comparing the elution position of the formic acid standard.

 

System suitability requirements

Theoretical plate number: ≥ 1,000
Symmetry factor: 0.5 - 1.5
Relative standard deviation (RSD): ≤ 2.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 50 µL
(Povidone K-30) 20 mg/mL in H2O
(Standard solution) 0.01 mg/mL of Formic acid in H2O

  1. 1.Formic acid
Chromatogram of formic acid in povidone
Column
Shodex RSpak KC-811 (8.0 mm I.D. x 300 mm)
Eluent
Diluted HClO4 (70 %) (1 in 700)
Flow rate
1.0 mL/min
Detector
UV (210 nm)
Column temp.
35 ℃

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