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.
Highlights
DEVELOPMENT OF A METHOD TO DETERMINE lethyl)-4-amino-1,2,4-triazole.The unfavorable demographic situation in Ukraine continues to deteriorate which is largely due to cardiovascular diseasesRELATED IMPURITIES IN BROMIDE 1-(β-PHENYLETHYL)-4-AMINO-1,2,4-TRIAZOLE TABLETSThe study proved that this method of impurity determination can be used for the analysis of bromide 1-(β-phenylethyl)-significantly affecting the mainNatalia Derevianko14-amino-1,2,4-triazole and inindicators of public health
It is seen that the impurity content of 4-amino-1,2,4-triazole in the tested tablets of bromide 1-(β-phenylethyl)-4-amino-1,2,4-triazole is within from 0.049 % to 0.195 %, that meets the requirements of regulatory documentation
We chose the method of high performance liquid chromatography (HPLC), which is widely used for standardization of drugs due to its high sensitivity, specificity and rapidity of analysis
Summary
DEVELOPMENT OF A METHOD TO DETERMINE lethyl)-4-amino-1,2,4-triazole.The unfavorable demographic situation in Ukraine continues to deteriorate which is largely due to cardiovascular diseasesRELATED IMPURITIES IN BROMIDE 1-(β-PHENYLETHYL)-4-AMINO-1,2,4-TRIAZOLE TABLETSThe study proved that this method of impurity determination can be used for the analysis of bromide 1-(β-phenylethyl)-significantly affecting the mainNatalia Derevianko14-amino-1,2,4-triazole and inindicators of public health. The related impurities of 4-amino-1,2,4-triazole in tablets of bromide 1-(ß-phenylethyl)-4amino-1,2,4-triazole were determined by HPLC. 20 mg of pharmacopoeial standard sample of bromide 1-(β-phenylethyl)4-amino-1,2,4-triazole are placed in a 10.00 ml volumetric flask, dissolved in 5 ml of purified water, 0.1 ml of comparison solution (a) is added and made up to the mark with eluent.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Technology transfer: innovative solutions in medicine
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
