A Guide to Updating HPLC Compendial Methods in Pharmaceutical Analysis
Drug producers refer to the United States Pharmacopeia-National Formulary (USP-NF), as well as European, Japanese, and British Pharmacopeias, for information on how to analyze drug substance, drug product, and associated excipients using various analytical techniques including high performance liquid chromatography (HPLC).
Manufacturers of generic drugs, as are most pharmaceutical companies in India, must prove that the generic compounds they produce are comparable to originator-brand name drugs. In addition, these generic drugs need to be manufactured in a way so as to maintain or lower the cost of the drugs production. As a result, these modified methods become an important part of their processes.
One of the ways to decrease costs is to 'adjust' compendial methods, which in many cases are written by using 5-micron columns to develop the original method. With the development in column technology in the last few years, columns with smaller particle size, providing shorter run times have been manufactured. These columns can be used to modernize the existing compendial methods. In some cases, paths to method adjustment are clear and easy. In other cases, a bit more work needs to be done.
In this webinar the presenter will discuss strategies for:
- Adjustments that can be made without validation
- Adjustments that require validation
- Basic (ICH) validation guidelines
By attending this webinar you will learn: Attendees will be equipped with an understanding of the vital role of compendial methods in pharmaceutical analysis, and how by making adjustments to them they can increase laboratory efficiency and decrease costs.
Presenter: Sunil B Lakhmapure (Technical Support Specialist Consumables, Agilent Technologies Debesh)
Holds 18 year plus experience in the analytical field with major exposure to LC/GC with Single quad , Triple Quad and High resolution (QToF) mass spectroscopy.
Started career in Pharma R&D as a scientist with hands on experience on high end instruments like LCMS, XRD & NMR .
Developed & published application notes using Chromatographic techniques on real world samples/issues at various levels.
