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. | Rt | Area | Height | Plates | Tailing factor | Resolution |
| 1 | 3.456 | 26922 | 6718 | 13126 | 1.193 | – |
| Total | _ | 26922 | 6718 | _ | _ | _ |
2. Test solution
2.1 Part of scale
| No. | Rt | Area | Height | Plates | Tailing factor | Resolution |
| 1 | 3.029 | 14741 | 2852 | 11268 | 0.680 | – |
| 2 | 3.445 | 8236 | 2027 | 12533 | 1.069 | 3.511 |
| Total | _ | 22976 | 4879 | _ | _ | _ |
2.2 Full scale
Conclusion
Using Xtimate® Sugar-Ca（7 .8×300mm，5 μm) under this chromatographic condition can meet the test requirements.
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