Determination of Formic Acid in Polyvidone K30

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Overview

Polyveridone K30 (PVPK30) has been widely used in medicine as one of the three major new pharmaceutical auxiliary materials for international advocacy. The most widely used is the adhesive of tablets and particles. PVP can also be used as a flow aid for capsules, depoisons and lubricants of eye agents, auxiliary solvents for injectors, dispersants for liquid agents, stabilizers of enzymes and thermistors. Polyveridone can also be synthesized with iodine for PVP-I disinfectant. PVP is also medically used as a cryogenic preservation agent. There are hundreds of drugs using PVP products as accessories.

In the Chinese Pharmacopoeia, the limit of methyl acid in polyvinone K30 is controlled. Using Ultisil® Alk C18(4.6×250mm,5μm) under this chromatographic condition can meet the test requirements.

Chromatographic conditions

Column: Ultisil® Alk C18 (4.6 × 250mm, 5μm)

Mobile phase: 0.01mol/L potassium dihydrogen phosphate/acetonitrile =95/5

Column temperature: 30℃

Detection wavelength: 210nm

Flow rate: 1.0ml/min

Injection volume: 20 μL

Chromatogram and data

1. Reference solution

No.RtAreaHeightPlatesTailing factorResolution
13.456269226718131261.193
Total _269226718 _ _ _

2. Test solution

2.1 Part of scale

No.RtAreaHeightPlatesTailing factorResolution
13.029147412852112680.680
23.44582362027125331.0693.511
Total _229764879 _ _ _

2.2 Full scale

Conclusion

Using Xtimate® Sugar-Ca(7 .8×300mm,5 μm) under this chromatographic condition can meet the test requirements.

If you have any problem or require further information, please contact info@welchmat.com.


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