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Validated LC-MS/MS Method for the Determination of Rosuvastatin in Human Plasma: Application to a Bioequivalence Study in Chinese Volunteers

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DOI: 10.4236/pp.2011.24044    9,903 Downloads   24,240 Views   Citations


A sensitive and selective liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of rosuvastatin in human plasma using gliclazide as an internal standard (IS). Rosuvastatin and gliclazide in plasma were extracted with ethyl acetate, separated on a C18 reversed phase column, eluted with mobile phase of acetonitrile-methanoic acid (0.1%) (60:40, v/v), ionized by positive ion pneumatically assisted electrospray and detected in the multi-reaction monitoring mode using precursor → product ions of m/z 482.1 → 258.1 for rosuvastatin and m/z 324.2 → 127.2 for IS, respectively. The calibration curve was linear (r2 > 0.99, n = 5) over the concentration range of 0.1 - 60 ng/mL. The speci?city, matrix effect, recovery, sensitivity, linearity, accuracy, precision, and stabilities were validated for rosuvastatin in human plasma. In conclusion, the validation results showed that this method was sensitive, economical and less toxic and it can successfully ful?ll the requirement of bioequivalence study of rosuvastatin calcium tablets in Chinese healthy volunteers.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

D. Zhang, J. Zhang, X. Liu, C. Wei, R. Zhang, H. Song, H. Yao, G. Yuan, B. Wang and R. Guo, "Validated LC-MS/MS Method for the Determination of Rosuvastatin in Human Plasma: Application to a Bioequivalence Study in Chinese Volunteers," Pharmacology & Pharmacy, Vol. 2 No. 4, 2011, pp. 341-346. doi: 10.4236/pp.2011.24044.


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