Quantitative Determination of Benzalconium Chloride in the Naltrexone Hydrochloride Nasal Spray

Разработка и регистрация лекарственных средств

E. V. Vorfolomeeva¹  V. V. Suslov¹  S. A. Kedik²  Yu. M. Domnina²  A. V. Meleshko² 

[1] JSC «Institute of Pharmaceutical Technologies»;Federal State Budget Educational Institution of Higher Education «MIREA – Russian Technological University»;

关键词: nasal spray;    naltrexone;    high-performance liquid chromatography;    validation;    gradient mode;   

DOI  :  10.33380/2305-2066-2020-9-4-121-127

来源: DOAJ

【 摘 要 】

Introduction. Benzalkonium chloride is widely used as a conservation agent in medicines. For quantitative determination, the methods described in the European and American Pharmacopoeias by chromatography using columns with nitrile sorbent are often used. However, in order to unify the methods and simplify the quality control technology in the production process, it is advisable to adapt the existing methods for new goals and objectives.Aim. To develop a method for the quantitative determination of benzalkonium chloride in a nasal spray containing a thermosensitive polymer Poloxamer 407 and validate it.Materials and methods. As an object of research, a naltrexone hydrochloride nasal spray was used. The quantitative determination of naltrexone in the test sample was developed using a Dionex UltiMate 3000 high-performance liquid chromatograph (Thermo Fisher Scientific, USA) equipped with a diode-matrix detector.Results and discussion. The paper explored the possibility of using an earlier developed method for the quantitative determination of naltrexone hydrochloride for the quantitative determination of benzalkonium chloride in the composition of a nasal spray. Based on the results obtained, changes were made to the quantitative determination method, and the sample preparation of the samples under study was adapted.Conclusion. As a result of the studies carried out, the most acceptable conditions for the preparation of the nasal spray for the quantitative determination of the preservative were selected. The developed technique provides for the chromatographic conditions previously used for the determination of naltrexone hydrochloride, which makes it possible to use the equipment as efficiently as possible in the analysis of the finished drug. The method has been validated and its specificity, linearity, correctness and precision have been proven.

【 授权许可】

Unknown