화학공학소재연구정보센터
Process Control and Quality, Vol.10, No.1, 41-57, 1997
High performance liquid chromatographic monitoring of process impurities in bulk drugs and formulations
The role of high-performance liquid chromatography in quality assurance of drugs and pharmaceuticals is reviewed. The emphasis has been laid on the current state of HPLC in monitoring of impurities in bulk drugs and formulations. Different HPLC approaches for monitoring of industrial processes of analgesics, antibiotics, anti-ulcer, anti-hypertensive and anti-tuberculosis drugs have been discussed. The latest trends in HPLC monitoring of enantiomeric purity of chiral drugs are surveyed. Its inherent advantages in isolation and identification of not only chemical additives but also degradation products of different formulations are discussed.