Development of standardization methods of Angiolin eye drops

Authors

  • I. A. Mazur Zaporizhzhia State Medical University, Ukraine,
  • R. R. Akopian Zaporizhzhia State Medical University, Ukraine,
  • L. Н. Cherkovska Zaporizhzhia State Medical University, Ukraine, https://orcid.org/0000-0002-0400-8494
  • I. V. Pavliuk Zaporizhzhia Research Experimental Forensic Center of the Ministry of Internal Affairs of Ukraine,
  • D. Yu. Skoryna Zaporizhzhia State Medical University, Ukraine,

DOI:

https://doi.org/10.14739/2409-2932.2020.3.216214

Keywords:

eye drops, angiolin ((S)-2, 6-diaminohexanoic acid 3-methyl-1, 2, 4-triazolyl-5-thioacetate), spectrum analysis

Abstract

 

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.

References

State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality (2014). Derzhavna Farmakopeya Ukrayiny [The State Pharmacopoeia of Ukraine] (2nd ed.). Vol. 1. Kharkiv: State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality. [in Ukrainian].

Grizodub, A. I., Evtifeeva, O. A., Proskurina, K. I., & Bezumova, O. V. (2014). Standartizovannaya protsedura validatsii spektrofotometricheskikh metodik kolichestvennogo opredeleniya lekarstvennykh sredstv v variante metoda pokazatelya pogloshcheniya. Soobshchenie 1 [A standardized procedure for the validation of spectrophotometric methods for the quantitative determination of drugs in a variant of the absorption index method. Message 1]. Farmakom, (1), 29-39. [in Russian].

Somov, E. E. (2017). Klinicheskaya oftal'mologiya [Clinical ophthalmology. Moscow] (4th ed.). Moscow: MEDpress-inform. [in Russian].

Verkhovna Rada of Ukraine. (1996, April 4). Pro likarski zasoby. Zakon Ukrainy 04.11.2018 № 123/96-VR [On Medicinal Products (No. 123/96-VR)]. [in Ukrainian]. https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80

Akopian, R. R. (2019). Shchodo stvorennia novoho oftalmolohichnoho likarskoho zasobu dlia likuvannia opikiv ochei ta katarakty [Regarding the development of a new ophthalmic drug for the treatment of eye burns and cataracts]. Aktualni pytannia suchasnoi medytsyny i farmatsii 2019. Zaporizhzhia. [in Ukrainian].

Georgievskii, V. P. (Ed.). (2011). Analiticheskaya khimiya v sozdanii, standartizatsii i kontrole kachestva lekarstvennykh sredstv [Analytical chemistry in the creation, standardization and quality control of medicines] (Vol. 1). Kharkiv : NTMT.

Bielenichev, I. F., Kucherenko, L. I., Mazur, I. A., Akopian, R. R., Khromylova, O. V., & Pavliuk, I. V. (2019). Experimental evaluation of the specific activity of the new Angiolin dosage form in the research corneal burn's condition. Zaporozhye Medical Journal, 21(6), 815-819. https://doi.org/10.14739/2310-1210.2019.6.186626

Bidnenko, O. S., Kucherenko, L. I., Mazur, I. A., & Tkachenko, G. I. (2016). Shchodo standartyzatsii tabletok L-lizynii 3-metyl-1,2,4-tryazolil-5-tioatsetat [About standardization of L-lysinum 3-methyl-1,2,4-thiazolyl-5-thioacetate tablets]. Current issues in pharmacy and medicine: science and practice, (2), 38-42. [in Ukrainian]. https://doi.org/10.14739/2409-2932.2016.2.70708

Hulevska, O. O., & Bidnenko, O. S. (2017). Shchodo standartyzatsii L-lizynii 3-metyl-1,2,4-tryazolyl-5-tioatsetatu [Regarding the standardization of L-lysine 3-methyl-1,2,4-triazolyl-5-thioacetate]. Khyst, 19, 495. [in Ukrainian].

Bidnenko, O. S. (2018). Veryfikatsiia spektrofotometrychnykh metodyk vyznachennia kilkisnoho vmistu tabletok "Anhiolin" [Verification of spectrophotometric methods for determining the quantitative content of tablets "Angiolin"]. Khyst, 20, 416. [in Ukrainian].

Kucherenko, L. I., Belenichev, I. F., & Akopian, R. R. (2019, November 14-15). Doklinichni doslidzhennia spetsyfichnoi aktyvnosti 1% ochnykh krapel Anhiolin v umovakh eksperymentalnoi katarakty [Preclinical studies of the specific activity of 1% of Angiolin eye drops in experimental cataracts]. Technological and biopharmaceutical aspects of developing of drugs with different orientation of action. Materials of Scientific and Practical Conference. Kharkiv. [in Ukrainian].

How to Cite

1.
Mazur IA, Akopian RR, Cherkovska LН, Pavliuk IV, Skoryna DY. Development of standardization methods of Angiolin eye drops. Current issues in pharmacy and medicine: science and practice [Internet]. 2020Nov.16 [cited 2024Oct.6];13(3). Available from: http://pharmed.zsmu.edu.ua/article/view/216214

Issue

Section

Original research