Quantitative determination of active substances of combined infusion solution by HPLC method

Introduction. The quantitative determination of substances and finished pharmaceutical products is a pivotal criterion in the assessment of their quality during serial production and control within the pharmaceutical market. This indicator ensures the accurate dosage of the active substance in the product, thereby ensuring the anticipated therapeutic effect. Consequently, the development of a uniform method for determining the quantitative content of active pharmaceutical ingredients in substances or dosage forms constitutes a significant undertaking within the domain of pharmaceutical analysis. Objective. This study aimed to develop and validate an HPLC method for the quantitative determination of active substances in a combined infusion solution. Material and methods. The objects of the analysis were an infusion solution containing L-arginine hydrochloride and L-glutamic acid, produced by Temur Med Farm LLC. The content of the active substances in the infusion solution was determined by high-performance liquid chromatography (HPLC) in gradient mode with ultraviolet (UV) detection. Results. A method for the quantitative determination of L-arginine and L-glutamic acid in an infusion solution is proposed with a relative error not exceeding ±0.83%. The developed method has been validated and meets the established criteria for linearity, accuracy, and precision. Conclusion. The validation results confirm that the developed high-performance liquid chromatography method for the quantitative determination of L-arginine and L-glutamic acid in this drug meets all the requirements and can be used to control its quality.