Analyzing Paraben Degradation in Parenteral Formulations with High-Performance Liquid Chromatography

Abstract

Background: Preservatives called parabens are frequently found in medicinal formulations and personal hygiene products. However, questions have been raised concerning their possible impact on health, leading to the need for reliable methods to determine their presence and degradation of products. Objective: This study aimed to create and validate a straightforward, accurate, dependable, and selective method for determining the levels of methyl and propyl parabens, as well as the breakdown product p-hydroxy benzoic acid. Additionally, a force degradation study was conducted to assess the stability of parabens in a parenteral formulation under various conditions. Method: Separation of the compounds was achieved using X-Bridge C18 (250 X 4.6 mm) 5μm column with a mobile phase composed of water (pH 3.0 with glacial acetic acid) and methanol (30:70). Detection was carried out at 254 nm using a UV detector with an injection volume of 20 μL and a flow rate of 1.0 mL/min. Force degradation studies included acid, base, oxidation, thermal, and photo-degradation. Results: Under the described conditions, the separation of p-hydroxy benzoic acid, methylparaben, and propylparaben was achieved in less than 12.0 minutes. The concentration ranges for p-hydroxy benzoic acid, methylparaben, and propylparaben were determined to be 1ng - 50 μg/mL, 100ng - 50μg/mL, and 100ng -12μ g/mL, respectively. The linearity, accuracy, and precision of the method were within acceptable ranges. Discussion: Maximum degradation of methylparaben was observed under base and neutral conditions in the first sample and under base and thermal conditions in the second sample. Similarly, maximum degradation of propylparaben was observed under base conditions in the first sample and under neutral and thermal conditions in the second sample. P-hydroxy benzoic acid degradation was observed under all conditions, with the highest degradation occurring in 0.1 N NaOH and 0.1 N HCl at 60°C. Conclusion: The developed method proved to be effective for the determination of methyl and propylparaben, along with their degradation product p-hydroxy benzoic acid, in pharmaceutical formulations. The results of the force degradation study provided valuable insights into the stability of parabens under various conditions, highlighting the importance of monitoring and controlling their degradation in pharmaceutical products.