HPLC has been established as a gold standard in the pharmaceutical industry. The main purposes for using HPLC are for identifying, quantifying, and purifying the individual components of the mixture. HPLC plays an important and critical role in the field of pharmaceutical industries and analysis, since it is used to test the products and to detect the raw ingredient used to make them i.e., qualitative and quantitative analysis. Moreover, the importance of HPLC uses in these fields falls under the stringent regulations established by the U.S. Food and Drug Administration (FDA). This obligates all pharmaceutical companies to detect the quality of their products by using the HPLC system before allowing them to sell it in the global market. The pharmaceutical products are evolving day by day and at the same time regulatory demands are increasing too; at times this poses challenges for HPLC and meeting the criteria of system suitability. It is important to understand the regulation and find a solution to address such requirements.
In this experiment, eight challenging pharmacopoeial and non-pharmacopoeial assay methods as listed in Table 1 were selected based on their injection volume, either 5 or 10 µL, which is lower than typical HPLC injection volume in combination with 100% organic solvent as diluent. Lower injection volume and 100% organic solvent as diluent poses a unique challenge of area precision in HPLC for extended sequence due to longer run time and/or several batches needed to be run back-to-back. All three combinations explained above can make the relative standard deviation for standard and bracketing standard injections area values run out of acceptance window leading to reanalysis.
