DEVELOPMENT OF A METHOD TO DETERMINE RELATED IMPURITIES IN BROMIDE 1-(β-PHENYLETHYL)-4-AMINO-1,2,4-TRIAZOLE TABLETS

Abstract

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.