RECENT APPROCHES FOR IMPURITY PROFILING IN PHARMACEUTICAL FORMULATIONS
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 1
Abstract
ABSTRACT In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The impurity may be developed either during formulation, or upon aging of both API’s and formulated API’s in medicines. The control of impurities in Formulated products and Active Pharmaceutical ingredients were regulated by various regulatory authorities like US-FDA, ICH, MHRA, TGA etc. Nowadays apart from purity profile there was an increasing essentiality of impurity profile by regulatory agencies. Hence Qualification of impurities which is essential for establishing the biological safety of an individual impurity. Thus it reveals the need and scope of impurity profiling of drugs in Pharmaceutical research. Various methods are used to isolate and characterize impurities in pharmaceuticals, such as, capillary electrophoresis, electron paramagnetic resonance, gas–liquid chromatography, gravimetric analysis, high performance liquid chromatography, solid-phase extraction methods, liquid–liquid extraction method, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction column chromatography, mass spectrometry, Nuclear magnetic resonance (NMR) spectroscopy, and RAMAN spectroscopy. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS, and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research. Keywords: Impurity profiling, HPLC, Spectroscopy, ICH guidelines.
Authors and Affiliations
Santosh Kumar S*, Praveen kumar V, Ajitha A, Rama Mohan Reddy T, Uma Maheshwar Rao V
Keywords
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