An overview of the recent trends in development of HPLC methods for determination of impurities in drugs.

An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the high-performance liquid chromatography (HPLC) methods which were developed and used for determination of process-related impurities in drugs have been reviewed. This review covers the time period from 1995 to 2001 during which around 450 analytical methods including all types of chromatographic and hyphenated techniques were reported. HPLC with UV detection was found to be the technique of choice for many workers and more than 200 methods were developed using LC-UV alone. A critical analysis of the reported data has been carried out and the present state-of-art of HPLC for determination of impurities of analgesic, antibiotic, anti-viral, anti-hypertensive, anti-depressant, gastro-intestinal and anti-neoplastic agents has been discussed.