Muhammad Jehangir
Novamed Group, Pakistan
Title: Stability indicating by HPLC method development and validation
Biography
Biography: Muhammad Jehangir
Abstract
High Performance Liquid Chromatography (HPLC) is an integral analy cal tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quan fy the various drug-related degradants that can form on storage or manufacturing, plus detect and quan fy any drug-related impuri es that may be introduced during synthesis. Forced degrada on studies of new chemical en es and drug products are essen al to help develop and demonstrate the speciï¬ city of such stability indica ng methods. In addi on to demonstra ng speciï¬ city, forced degrada on studies can be used to determine the degrada on pathways and degrada on products that could form during storage, and facilitate during formula on, development, manufacturing and packaging. For marke ng applica ons, current FDA and ICH guidance recommends inclusion of the results, including chromatograms of stressed samples, demonstra on of the stability-indica ng nature of the analy cal procedures, and the degrada on pathways of the API in solid state, solu on, and drug product. A review of literature reveals that a large number of methods reported over the period of last 3 – 4 decades under the nomenclature ‘stability-indica ng’, but most of the reported methods fall short in mee ng the current regulatory requirements. Hence a systema c approach for the development of validated SIAMs that should meet the current ICH and regulatory requirements. The following will provide some sugges ons for performing forced degrada on studies based upon available guidance from the ICH and FDA.