Simultaneous determination of the contens of paracetamol and ibuprofen active ingredients in the solution for infusion using the high performance liquid chromatography method

Backround and Aim: Ibuprofen is an orally administered nonsteroidal anti-inflammatory drug (NSAID). It is used in the treatment of rheumatoid arthritis, osteoarthritis, and dysmenorrhea. It is also used as an antipyretic and analgesic for mild to moderate pain. Paracetamol, a paraaminophenol derivative, is an analgesic and antipyretic raw material. It is also known as a metabolite of paracetamol phenacetin. The combination of paracetamol and ibuprofen is known to provide better pain relief compared to either drug alone. Numerous validated simultaneous analytical methods exist for the combination dosage form of ibuprofen and paracetamol. However, few examples exist for the solution for infusion form. Pharmacopoeias contain methods for the traditional dosage form of ibuprofen, paracetamol, and their various formulations, but not for the combination. Accordingly, there is virtually no method capable of quantitatively determining two active ingredients simultaneously using a high-performance liquid chromatography method, particularly in a product in the form of an infusion solution. Various methods have been reported for the separate determination of ibuprofen and paracetamol in pharmaceutical samples and biological systems using High-Performance Liquid Chromatography. While conventional high-performance liquid chromatography methods are widely used in the analysis of combinations containing paracetamol, they often suffer from disadvantages such as long analysis times, high solvent consumption, and multi-stage preparation processes. These factors, which limit the applicability of these methods in routine laboratory settings, highlight the need for more practical, rapid, and cost-effective analytical approaches. In this context, the development of new chromatographic methods that are low-cost, rapid, sensitive, selective, and reliable, while also being easy to apply, is of paramount importance. The aim was to develop a low-cost, rapid, sensitive, selective, reliable, and easily applicable analytical method for the analysis of the active ingredients paracetamol and ibuprofen in an infusion solution using high-performance liquid chromatography, and to perform simultaneous quantitative determinations of both active ingredients. Materials and Methods: Analysis was performed at room temperature (25 degrees Celsius). The mobile phase was 1 L of pure water containing 1 mL of orthophosphoric acid, using a gradient flow method. The total analysis time was 30 minutes. The stationary phase column was a Waters XBridge C18 column with 250 mm × 4.6 mm × 3.5 micrometers. The chromatographic method used was a reversed-phase High-Performance Liquid Chromatography system. Results: The method validation required for the quantitative testing of the method was completed, and all values met the relevant criteria. Conclusion: The analytical method developed in this study allows the simultaneous determination of both active substances and has been validated in accordance with the International Council for Harmonization guidelines. Furthermore, rapid, reliable, and accurate analytical studies can be performed for both single and double agents in quality control laboratories where serial analyses are performed.