Home|Journals|Articles by Year|Audio Abstracts
 

Original Article

J App Pharm Sci. 2023; 13(1): 201-211


UPLC-Q-TOF-MS method development and validation for simultaneous analysis of dipyridamole and its related impurities

T. Menaka, Ramya Kuber.




Abstract
Cited by 2 Articles

A sensitive, specific, precise, and cost-effective ultra-performance liquid chromatography to quadrupole time-of-flight mass spectrometry technique for analyzing dipyridamole and its associated impurities was developed and validated. A high-strength silica T3 column (100 × 3 mm, 3.5 µ) was used as a stationary phase for chromatographic separation, and a mobile phase of 1% acetic acid in water (A) and acetonitrile (B) was delivered in gradient with a flow rate of 0.6 ml/ minute for sample injected at 5 µl volume with diode array detection at 200–400 nm. Analytes were ionized for mass spectrometric detection, utilizing a positive-polarity ESCi source with a Q-TOF-MS analytical range of 50–1,500 m/z. The developed method was validated in accordance with the USFDA’s analytical method validation requirements and was proven to be successful in resolving dipyridamole.

Key words: UPLC-Q-TOF, Dipyridamole, Impurities, Validation Resolution, and USFDA.






Full-text options


Share this Article


Online Article Submission
• ejmanager.com




ejPort - eJManager.com
Refer & Earn
JournalList
About BiblioMed
License Information
Terms & Conditions
Privacy Policy
Contact Us

The articles in Bibliomed are open access articles licensed under Creative Commons Attribution 4.0 International License (CC BY), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.