Development and validation of modern chromatographic methods for analysis of pharmaceutical drug products

Abstract

Pharmaceutical drug products play a vital role in human progress by finding curing for diseases. Today, a majority of the drugs used are of synthetic origin. They are produced in bulk and used for their therapeutic effects in pharmaceutical formulations. These formulations deliver the drug substances in a stable, non-toxic and acceptable form, ensuring its bio-availability and therapeutic activity. The end user of the drug product has to be assured of the medicine s quality, which makes suitable testing of the materials an area of great concern. Thus, the analytical activities concerning purities in drug products are among the most important issues in modern pharmaceutical analysis. This subject or topic for this research activity is selected based on the increasing need for the pharmaceutical industry to develop suitable analytical methods. Among various other available techniques, the scope of work was focused on the modern chromatographic techniques such as HPLC and UPLC, which are very powerful and sophisticated techniques and have a wide spectrum of applications in the pharmaceutical industry. Five chromatographic methods were developed for different pharmaceutical drug products. The first method was developed for the estimation of pioglitazone, glimepiride and glimepiride impurities, i.e., related compound B and related compound C from combination drug product containing pioglitazone, glimepiride and metformin hydrochloride. The second method was developed for the estimation of nevirapine and its impurities in combination drug product containing lamividune, zidovudine and nevirapine. The third method was developed for the estimation of rabeprazole sodium in formulated drug product containing rabeprazole sodium. The fourth method was developed for the estimation of pioglitazone, glibenclamide, and glibenclamide impurities A and B from combination drug product. The fifth method was developed for the estimation of paracetamol, tramadol hydrochloride and domperidone in combination drug product. newline newline newline