Optimization of HPLC method for control of propranolol hydrochloride impurities in liquid medicine for oral use in pediatrics

Abstract

Abstract Propranolol hydrochloride is approved in Ukraine as one of the drugs for the treatment of infantile hemangiomas in pediatrics, however, there are no industrially produced drugs, which necessitates the development and small-scale production. To ensure their proper quality, it is important to implement high-precision analytical control methods, to determine accompanying impurities that may affect the safety and effectiveness of therapy in children.

Aim. To optimize the liquid chromatography method for determining impurities of the active pharmaceutical ingredient in the drug "Propranolol hydrochloride, 4.28 mg/ml, oral solution", manufactured by pharmacy No. 2 CHEMOTEKA of the Pharmaceutical Department of PE "Infusia", intended for use in pediatrics.

Materials and methods. The study was carried out as part of the development of the medicinal product “Propranolol hydrochloride, 4.28 mg/ml, solution for oral administration” (pharmacy No. 2 CHEMOTEKA, PE "Infusia"). Impurities were controlled by liquid chromatography according to the US Pharmacopoeia method “Propranolol hydrochloride for injection”. Method verification was carried out considering the requirements of international standards and the SPhU.

Results. The proposed method for determining the content of related impurities is characterized by high specificity, linearity in the range of 0.5 - 1.6 mg/ml, accuracy, precision, confirmed reproducibility and reporting limit at the level of no more than 0.1%. Additionally, the stability of solutions for 24 hours has been established, which ensures the convenience of its use in routine pharmaceutical analysis.

Conclusions. The optimized liquid chromatography technique provides reliable determination of impurities in the medicinal product "Propranolol hydrochloride, 4.28 mg/ml, oral solution", meets international validation requirements and can be used in routine quality control. The results obtained confirm the feasibility of its use to improve the safety and effectiveness of therapy with the study drug