DEVELOPMENT OF A METHOD TO DETERMINE RELATED IMPURITIES IN BROMIDE 1-(β-PHENYLETHYL)-4-AMINO-1,2,4-TRIAZOLE TABLETS
Aim: to develop a modern method to determine related impurities in bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole tablets by high performance liquid chromatography (HPLC).
Methods: The development of a method to determine related impurities in bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole tablets involved an already developed method for the determination of 4-amino-1,2,4-triazole impurities in tablets by HPLC. The test solution and the comparison solution were prepared and chromatographed alternately according to the developed methods. At least three chromatograms were obtained for each solution for the purpose of the reliability of the study results.
Results: Scientists of the Scientific-Production Association "Farmatron" jointly with the staff of the Pharmaceutical Chemistry Department of Zaporizhzhia State Medical University under the leadership of Professor Mazur I. A. obtained a new original compound – bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole (conditional name "Hypertril"), which exhibits antihypertensive, anti-ischemic and antioxidant properties. It is known that the quality of medicines largely depends on the degree of their purity. Therefore, in accordance with the regulatory documentation and quality control methods of medicines, it is mandatory to carry out tests for impurities. According to the results, the content of impurities of 4-amino-1,2,4-triazole in the tested tablets of bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole is in the range from 0.049 % to 0.195 % which meets the requirements of regulatory documentation. No peaks of unidentified impurities were detected on the chromatograms of the test solution.
Conclusion: Therefore, a modern method to determine the related impurity of 4-amino-1,2,4-triazole in tablets of bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole has been developed. The methodology is reproducible, accurate and meets the requirements of regulatory documentation.
Parniuk, N. V., Belenichev, І. F., Kucherenko, L. I. (2015). Influence of new antianginal and antihypertensive medication «Hypertril» on the biochemical and morphological parameters of neurodestruction and violations of cognitive functions related to them, at the experimental arterial hypertension. Inter-medical, 1 (7), 48–53.
Mazur, I. A., Belenichev, I. F., Kucherenko, L. I., Chekman, I. S., Kolesnik, Y. M. et. al. (2014). Pat. No. 105618 UA. The use of bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole as an active basis of drugs for the correction of dysfunction of the nitroxydergic system of the target organ – the brain in acute cerebrovascular disorders. MPK: A61K 31/4196, A61P 9/10, A61P 25/00. No. a201312038; declareted: 14.10.2013; published: 26.05.2014, Bul. No. 10.
Mazur, I. A., Belenichev, I. F., Kucherenko, L. I., Chekman, I. S., Kolesnik, Y. M. et. al. (2013). Pat. No. 84351 UA. The use of bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole as an active drug base for the correction of disorders of the nitroxydergic system in atherosclerosis and diabetes. MPK: A61K 31/41 (2006.01), A61P 9/10 (2006.01). No. a201212500; declareted: 02.11.12; published: 25.10.13, Bul. No. 20.
Belenichev, I. F., Kucherenko, L. I., Volchik, Y. A., Nagorna, O. O., Mazur, I. A., Parnyuk, N. V. et. al. (2014). Search of substances with the cardioprotective activity in the series of derivatives of halogenides 1-alkyl- and carboxyalkyl-4-ylideneamino-1,2,4-triazole. Clinical Pharmacy, 18 (3), 35–41. doi: http://doi.org/10.24959/cphj.14.1304
Belenichev, I. F., Mazur, І. A., Kucherenko, L. І. et. al. (2012). NO-mimetic action of a new antianginal drug MT in experimental myocardial infarction. Clinical pharmacy, 16 (3), 36–40.
Belenichev, І. F., Kucherenko, L. І., Nahorna, О. О., Volchyk, Yu. A., Mazur, I. A., Parniuk, N. V. (2014). Metabolite tropic mechanisms of cardioprotective effect of new antianginal and antihypertensive drug “Hуpertril” in experimental ischemia of myocardium. Odessa Medical Journal, 6, 22–26.
Kucherenko, L. I., Parniuk, N. V., Khromylova, O. V. (2018). Validation of the quantitation methods of 1-(β-phenylethyl)-4-amino-1,2,4- triazole bromide substance by spectrophotometric method. Asian Journal of Pharmaceutical and Clinical Research, 11 (2), 231–234. doi: http://doi.org/10.22159/ajpcr.2018.v11i2.22740
Kucherenko, L. I., Parniuk, N. V., Moryak, Z. B. (2015). Development of quantitative determination methods for the stepwise control of «Hypertril» tablets production. Pharmaceutical Journal, 2, 60–63.
Parniuk, N. V., Kucherenko, L. І., Portna, О. О. (2016). Selection of rational excipients to create tablets "Hypertril" by direct compression Message 2: Study of the effect of excipients on the technological characteristics of powder masses. Pharmaceutical Journal, 1, 34–40.
Parniuk, N. V., Kucherenko, L. І., Moryak, Z. B. (2015). Regarding antihypertensive tablets standardization. Current issues of pharmaceutical and medical science and practice, 3, 25–29. doi: http://doi.org/10.14739/2409-2932.2015.3.52619
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