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.
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