Development of standardization methods of Angiolin eye drops

The eyes are one of the most vulnerable human organs. An important place among all traumatic injuries belongs to burns, which are characterized by a large number of adverse consequences. Today, the pharmaceutical market of Ukraine is mainly occupied by drugs of foreign origin, therefore, the urgent task of modern pharmacy is to create and expand the range of the domestic pharmaceutical market and the relative cheapness of the drug in comparison with other drugs, in a future. The employees of the Department of Pharmaceutical Chemistry of Zaporizhzhia State Medical University (ZSMU), together with specialists from NPO Pharmatron, synthesized a new compound called “Angiolin” ((S)-2,6-diaminohexanoic acid 3-methyl-1,2,4-triazolyl -5-thioacetate). The obtained compound has anti-inflammatory, wound-healing, reparative effect .A rational dosage form in the form of eye drops was proposed and created for the new drug. The aim of the work is to develop a technique for standardizing the active substance in “Angiolin” eye drops ((S)-2,6-diaminohexanoic acid 3-methyl-1,2,4-triazolyl-5-thioacetate) by spectrophotometry. Materials and methods: A certified substance of аngiolin was used in the research (manufacturer: State Enterprise “Plant of Chemical Reagents” of the Scientific and Technological Complex “Institute of Single Crystals” of the National Academy of Sciences of Ukraine, series 2451117). The spectrophotometric method for the analysis of the аngiolin substance was taken as a basis. The studies were carried out using an Optizen POP spectrophotometer, measurements were carried out at a wavelength in the range of 200–300 nm, a cuvette thickness of 10 mm. Results. Studies were performed on six series of 1% eye drops “Angiolin”, which was quantified by spectrophotometric method. It was found that the content of аngiolin in eye drops was in the range of 0.00981–0.01011 g/ml. Thus, in terms of the content of the active substance, the studied series of eye drops meets the requirements of the State Pharmacopoeia. Subsequently, another five series of «Angiolin» eye drops were analyzed, which also met the pharmacopoeial requirements for the content of the active substance (0.00980–0.01015 g/ml). We believe that the developed method for standardizing eye drops is reproducible. Conclusion: In the research, we have developed a method for standardizing the active substance in “Angiolin” eye drops by spectrophotometry. The developed technique is reproducible, accurate, and in the future, after its validation, it can be used in the standardization of the active substance in various dosage forms.