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

T. Menaka; Ramya Kuber

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.

Reference

Acharya, Daniel A, Gyadangi B, Ramsamy S. Isolation, characterization of a potential degradation product of aspirin and an HPLC method for quantitative estimation of its impurities. J Chrom Sci, 2015; 53(9):1491-7. https://doi.org/10.1093/chromsci/bmv043

Barberi-Heyob M, Merlin JL, Pons L, Calco M, Weber B. A sensitive isocratic liquid chromatography assay for the determination of dipyridamole in plasma with electrochemical detection. J LiqChrom, 2006; 17:1837-48.ß https://doi.org/10.1080/10826079408013462

Bridle JH, Brimble MT. A stability indicating method for dipyridamole. Informa Heal Drug Dev Ind Pharm, 2008; 19:371-81. https://doi.org/10.3109/03639049309038773

Bult H, Fret HR, Jordaens FH, Herman AG. Dipyridamole potentiates platelet inhibition by nitric oxide. Thromb Haemost, 1991; 66(3):343-9. PMID: 1746006. https://doi.org/10.1055/s-0038-1646418

Center for Drug Evaluation and Research. Validation of chromatographic methods. Docket ID: FDA-2013-S-0610, 1994. Available via https://www.fda.gov/media/75643/download

Fontani F, Finardi GP, Targa G, Besana GP, Ligorati M. Purity evaluation of dipyridamole by high-performance liquid chromatography. JChrom A, 1983; 280:181-7. https://doi.org/10.1016/S0021-9673(00)91557-7

Hassan H, Hammud, Fawzy A. El Yazbib, Mohamad E. Mahrous, Ghassan M. Sonji, Nada M. Sonji. Stability-indicating spectrofluorimetric and RP-HPLC methods for the determination of aspirin and dipyridamole in their combination. OpeSpect J, 2008; 2:19-28. https://doi.org/10.2174/1874383800802010019

ICH Q2 (R1). Validation of analytical procedures: text and methodology. International Conference on Harmonization, 2005.

Rajput AP, Sonanis MC. Development and validation of a rapid RP-UPLC method for the determination of aspirin and dipyridamole in combined capsule formulation. Int J Pharm Pharma Sci, 2011; 3:156-60.

Rao AS, Rao K, Dadichand AS, Punna Rao AML, Balaswami B. Development and validation of RP-HPLC method for assay of dipyridamole in formulations. J Pharm Sci Res, 2016; 8(5):256-9.

USFDA. Analytical procedures and methods validation for drugs and biologics. Docket ID: FDA-2015-N-0007, 2015. Available via https:// www.fda.gov/media/87801/download

Vaghela B, Rao SS, Reddy SP. Development and validation of a stability indicating RP-LC method for the estimation of process related impurities and degradation products of dipyridamole retard capsules. Int J Pharm Pharm Sci, 2012; 4:615-22.

Yogesh D Bommegowda, Dinesh B Shenoy, Menaka T, Chethan BP, Nagaraja G, Fazil Baig, Sandeep K N, Venkanna Babu. Synthesis of novel pyrimido-[5, 4-d] pyrimidines by sequential nucleophillic substitution reaction. J Chem Pharm Res, 2012; 11:4888-93.

Zhang J, Miller RB, Jacobus R. Development and validation of a stability-indicating HPLC method for the determination of degradation products in dipyridamole injection. Chromatographia, 1997; 44:247-52. https://doi.org/10.1007/BF02466389

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