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Evaluation of Aspirin and Dipyridamole Using Low Concentration Potassium Fluoride as a Stabilizer in Human Plasma by LC-MS/MS Mode
Corresponding Author(s) : P.A. Vivekanand
Asian Journal of Chemistry,
Vol. 28 No. 11 (2016): Vol 28 Issue 11
Abstract
The objective of this work is to develop a stable, specific, accurate and precise bioanalytical method for the determination of aspirin and dipyridamole in human plasma using LC-ESI-MS/MS. Sample extraction is carried out using solid phase extraction technique. Methanol: 0.10 % formic acid in water (90:10 v/v) is used as a mobile phase and separation was achieved in 3 min on a Chromolith® high resolution, 100 × 4.6 mm, 5 μ analytical column. Detection is performed using MRM transitions 178.9/136.8 with positive polarity for aspirin and 525.7/505.6 with negative polarity for dipyridamole on a API 4000 mass spectrometer. This method is specific and calibration range is found linear over the range 5.073 to 802.820 ng/mL for aspirin and 50.051 to 4004.069 ng/mL for dipyridamole. Method is validated as per EMA and USFDA guidance on bioanalytical method. Method is successfully applied to conduct bioequivalence studies.
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- H.O. Kaila, M.A. Ambasana and A.K. Shah, Int. J. ChemTech. Res., 3, 459 (2011).
- P. Vivek Sagar, T. Samidha, M. Vamshi Krishna and S.S. Rani, Int. J. Pharm. Sci. Res., 5, 4858 (2014).
- B.S. Vaghela, S.S. Rao and P.S. Reddy, Int. J. Pharmacy Pharm. Sci., 4, 615 (2012).
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References
http://www.rxlist.com/aggrenox-drug.htm.
G.M. Tyce, V. Fuster and C.A. Owen Jr, Res. Commun. Chem. Pathol. Pharmacol., 26, 495 (1979).
M.M. Reddy, V. Sandeep, P. Suresh Kumar and R.S. Reddy, J. Pharm. Res., 5, 4137 (2012).
N.R. Gajula, Sci. Pharm., 80, 923 (2012); doi:10.3797/scipharm.1206-12.
S.R. Polagani, N.R. Pilli and V. Gandu, J. Pharm. Anal., 2, 206 (2012).
J. Brisson, C.R. Bowerbank and P.K. Bennett, Tandam labs, AAPS Conference, Baltimore, Maryland (2004).
http://www.qps.com/posters/QPS%202009-002_17.pdf.
K. Prakash, R.R. Kalakuntla and J.R. Sama, African J. Pharmacy Pharmacol., 5, 244 (2011).
A.P. Rajput and C.M. Sonanis, Int. J. Pharmacy Pharm. Sci., 3, 156 (2011).
Y. Rama, K. Reddy, S.G. Reddy, M.R.P. Reddy and K. Mukkanti, J. Chem. Pharm. Res., 5, 181 (2013).
S.S. Panda, Int. J. Pharm. Technol. Res., 2, 269 (2010).
P. Mishra and A. Dolly, Indian J. Pharm. Sci., 68, 365 (2006); doi:10.4103/0250-474X.26682.
H.O. Kaila, M.A. Ambasana and A.K. Shah, Int. J. ChemTech. Res., 3, 459 (2011).
P. Vivek Sagar, T. Samidha, M. Vamshi Krishna and S.S. Rani, Int. J. Pharm. Sci. Res., 5, 4858 (2014).
B.S. Vaghela, S.S. Rao and P.S. Reddy, Int. J. Pharmacy Pharm. Sci., 4, 615 (2012).
S.K. Bae, K.A. Seo, E.J. Jung, H.S. Kim, C.W. Yeo, J.H. Shon, K.M. Park, K.H. Liu and J.G. Shin, Biomed Chromatogr., 22, 590 (2008); .
W. Na, F. Xu, Z. Zhang, C. Yang, X. Sun and J. Li, Biomed Chromatogr., 22, 149 (2008); doi:10.1002/bmc.909.
http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.