Analytical procedures are essential for quality control of drug substances and drug products. They accurately determine the identification, physical characteristics, content, impurities, and efficacy throughout the shelf-life of pharmaceutical products.
As part of the master’s thesis, the suitability of a novel analytical procedure for stability testing of pantoprazole in its sodium form was assessed. The suitability of an analytical procedure may be rigorously assessed by subjecting the drug product to extreme conditions that are more severe than regular ambient conditions (e.g., significantly elevated temperature). This approach facilitates the evaluation of the analytical procedure’s capacity to detect any alterations in the quality of product, for instance, a rise in the level of impurities.
The experimental work was carried out on drug substances and tablets from two different manufacturers. The initial phase required the selection of appropriate stress conditions to exclusively induce the formation of primary degradation products. According to the American and European Pharmacopoeia known impurities of pantoprazole, we were able to identify all, concurrently monitoring the decrease in pantoprazole content in correlation to the increase in degradation products. The designated target range for degradants was between 5 and 20%, a challenging parameter to meet for such stable drug substance, as evidenced in our study. Certain conditions applied to the drug substance samples (e.g., 0,1 M HCl and 0,3 % hydrogen peroxide) were determined to be overly rigorous, resulting in the formation of secondary and tertiary products. Conversely, the targeted percentage of degradation was more effectively achieved for the tablet samples, likely attributable to the gastro-resistant coating’s preservation of the pantoprazole within.
Our study provided valuable insights into the stability of pantoprazole, underscoring its susceptibility to acidic conditions, elevated temperatures and humidity, and oxidation condition. Additionally, the study confirmed that the chromatographic peaks of drug substance and impurities were well separated and spectrally homogeneous.
Collectively, these observations substantiate that the subjected methods for testing the stability of PPT are suitable for stability testing, thereby achieving main objective of our master’s thesis.
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