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

T. Menaka Ramya Kuber   

Open Access   

Published:  Jun 16, 2022

Abstract

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.


Keyword:     UPLC-Q-TOF dipyridamole impurities validation resolution USFDA.


Citation:

Menaka T, Kuber R. UPLC-Q-TOF-MS method development and validation for simultaneous analysis of dipyridamole and its related impurities. J Appl Pharm Sci, 2022. Online First.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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