Determination of aluminum in parenteral solution by high performance liquid chromatography with fluorescence detector

"Determination of aluminum assay in parenteral solution using high performance liquid chromatography method connected to fluorescence detector", Trakya University, Institute of Health Science, Basic Pharmaceutical Sciences Department, Master Thesis, Edirne, 2025. Background and Aim: Aluminum is one of the cations found in nature in ionic form. In addition to causing toxicity, aluminum exposure can also cause different side effects such as bone pain, proximal muscle weakness and mental status changes. Especially in patients with renal failure, aluminum may not be excreted sufficiently. In this case, aluminum can accumulate in some tissues and cause toxicity. Aluminum is widely used in different areas such as packaging and food additives. In the pharmaceutical industry, since it is used as an adjuvant, we can say that the amount of aluminum taken with drugs is much higher than the amount taken with food (1). Therefore, monitoring the amount of aluminum in pharmaceutical preparations used in the treatment of renal failure is very important in order to prevent aluminum that patients will be exposed to. In this thesis study, the aim is to develop a high-performance liquid chromatography method coupled to a fluorescence detector to determine the amount of aluminum in paricalcitol injection solution, which is indicated for the prevention and treatment of secondary hyperparathyroidism seen with chronic renal failure in patients on hemodialysis, and to provide validation and verification of the analytical method in determining the amount of aluminum precisely. Material and Methods: The analysis was carried out at room temperature 25oC, and the mobile phase was an equal mixture of Ammonium Acetate buffer and 8-Hydroquinoline solution. The flow rate was determined as 1,0 milliliter/minute and the total analysis time was determined as 8 minute The method complies with the linearity criterion for the quantification test. Aluminum Correlation coefficient (r); 1,0000, (r2); is greater than 0,9999. The point where the line intersects the y-axis, the slope % value of the line is 5,07%. Results: In this study, the amount of aluminum in parenteral solutions was successfully determined using the high-performance liquid chromatography method coupled to a fluorescence detector. The validation study conducted with the developed method showed high sensitivity and selectivity. The accuracy and repeatability parameters in the validation studies proved the reliability of the method. The rapidity and effectiveness of the method reveal its suitability for routine analysis. Conclusion: This method, which was developed to detect the aluminum molecule accurately and reliably, has been validated according to ICH. It can also be used in serial analyses to provide accurate, safe and fast results in quality control laboratories.