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Development and Validation for Related Substances of Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using High Performance Liquid Chromatography
Corresponding Author(s) : Sriram Valavala
Asian Journal of Chemistry,
Vol. 29 No. 11 (2017): Vol 29 Issue 11
Abstract
A simple, sensitive, robust stability indicating gradient high performance liquid chromatographic method was developed for the quantitative determination of related substance of dipyridamole in tartaric acid based pellets of dipyridamole modified release capsules. This method is able to separate all process known, degradation impurities which includes three newly identified potential degradant impurities. The method was developed by using YMC pack pro C8 (150 mm × 4.6 mm) 5 μm column with mobile phase containing mixture of mobile phase A (0.02 M buffer, pH 4.70, acetonitrile and methanol solution) and mobile phase B (0.02 M buffer, pH 4.70, acetonitrile and methanol solution). The flow rate was 1.5 mL/min with column temperature of 30 °C and detection wavelength at 295 nm. The dipyridamole substance and drug product was subjected to the forced degradation conditions and impurities were well resolved from dipyridamole and its impurities. This proved the stability-indicating nature of the method and validated as per ICH guidelines.
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- http://www.medicines.org.uk/emc/medicine/304/SPC/.
- A.R. Zoest, J.E. Watson, C.T. Hung and S.A. Wanwimolruk, J. Liq. Chromatogr., 14, 1967 (1991); https://doi.org/10.1080/01483919108049666.
- A.S. Rao, M.K. Rao, A.S. Dadichand, A.M.L. Punna Rao and B. Balaswami, J. Pharm. Sci. Res., 8, 256 (2016).
- J.H. Bridle and M.T. Brimble, Informa Healthcare Drug Develop. Indus. Pharm., 19, 371 (1993); https://doi.org/10.3109/03639049309038773.
- J. Zhang, R.B. Miller and R. Jacobus, Chromatographia, 44, 247 (1997); https://doi.org/10.1007/BF02466389.
- B.K. Vaghela, S.S. Rao and P.S. Reddy, Int. J. Pharm. Pharm. Sci., 4(Suppl. 1), 615 (2012).
- K. Prakash, R.R. Kalakuntla and J.R. Sama, Afr. J. Pharm. Pharmacol., 5, 244 (2011); https://doi.org/10.5897/AJMR10.414.
- M.C. Sonanis and A.P. Rajput, Int. J. Pharm. Pharm. Sci., 3, 145 (2011).
- H.H. Hammud, F.A, El-Yazbi, M.E. Mahrous, G.M. Sonji and N.M. Sonji, The Open Spectrosc. J., 2, 19 (2008); https://doi.org/10.2174/1874383800802010019.
- Z. Kopitar and H. Weisenberger, Arzneimittelforschung, 21, 859 (1971).
- D.B. Bandarabadi, M.P. Hamedani and M. Amini, Daru, 7, 14 (1999).
- J. Brisson, C.R. Bowerbank and P.K. Bennett, Quantitative Determination of Dipyridamole in Human Plasma Using Liquid Chromatography and Electrospray Ionization Tandem Mass Spectrometry, Tandam Labs, AAPS Conference, Baltimore, Maryland, USA (2004)
- T. Qin, F. Qin, N. Li, S. Lu, W. Liu and F. Li, Biomed. Chromatogr., 24, 268 (2010); https://doi.org/10.1002/bmc.1283.
- Text on Validation of Analytical Procedures Q2 (R1) in; ICH, Harmonised Tripartite Guideline (2005).
- Text on Stability Testing of New Drug Substances and Products Q1A (R2) in; ICH, Harmonised Tripartite Guideline (2003).
References
http://www.medicines.org.uk/emc/medicine/304/SPC/.
A.R. Zoest, J.E. Watson, C.T. Hung and S.A. Wanwimolruk, J. Liq. Chromatogr., 14, 1967 (1991); https://doi.org/10.1080/01483919108049666.
A.S. Rao, M.K. Rao, A.S. Dadichand, A.M.L. Punna Rao and B. Balaswami, J. Pharm. Sci. Res., 8, 256 (2016).
J.H. Bridle and M.T. Brimble, Informa Healthcare Drug Develop. Indus. Pharm., 19, 371 (1993); https://doi.org/10.3109/03639049309038773.
J. Zhang, R.B. Miller and R. Jacobus, Chromatographia, 44, 247 (1997); https://doi.org/10.1007/BF02466389.
B.K. Vaghela, S.S. Rao and P.S. Reddy, Int. J. Pharm. Pharm. Sci., 4(Suppl. 1), 615 (2012).
K. Prakash, R.R. Kalakuntla and J.R. Sama, Afr. J. Pharm. Pharmacol., 5, 244 (2011); https://doi.org/10.5897/AJMR10.414.
M.C. Sonanis and A.P. Rajput, Int. J. Pharm. Pharm. Sci., 3, 145 (2011).
H.H. Hammud, F.A, El-Yazbi, M.E. Mahrous, G.M. Sonji and N.M. Sonji, The Open Spectrosc. J., 2, 19 (2008); https://doi.org/10.2174/1874383800802010019.
Z. Kopitar and H. Weisenberger, Arzneimittelforschung, 21, 859 (1971).
D.B. Bandarabadi, M.P. Hamedani and M. Amini, Daru, 7, 14 (1999).
J. Brisson, C.R. Bowerbank and P.K. Bennett, Quantitative Determination of Dipyridamole in Human Plasma Using Liquid Chromatography and Electrospray Ionization Tandem Mass Spectrometry, Tandam Labs, AAPS Conference, Baltimore, Maryland, USA (2004)
T. Qin, F. Qin, N. Li, S. Lu, W. Liu and F. Li, Biomed. Chromatogr., 24, 268 (2010); https://doi.org/10.1002/bmc.1283.
Text on Validation of Analytical Procedures Q2 (R1) in; ICH, Harmonised Tripartite Guideline (2005).
Text on Stability Testing of New Drug Substances and Products Q1A (R2) in; ICH, Harmonised Tripartite Guideline (2003).