Abstract
Combination drug products containing amlodipine and atorvastatin are widely marketed and used in the treatment of concomitant hypertension and dyslipidemia. A rapid, simple and sensitive high performance liquid chromatography–tandem mass spectrometry (HPLC–MS–MS) method for determination of atorvastatin and amlodipine in plasma of hypertensive patients has been developed and validated to be used for therapeutic drug monitoring. The plasma samples were subjected to methanol protein precipitation. Chromatographic separation was performed on a C18 column using a gradient elution. The mobile phase consisted of 0.1% of formic acid in water and 0.1% of formic acid in acetonitrile and was pumped at a flow rate of 0.4 mL min−1. Detection of analytes was achieved by tandem mass spectrometry with electrospray ionization (ESI) interface in positive ion mode. The calibration curves were linear over the range of 0.46–1,000 ng mL−1. The intra- and inter-day precisions were within 12.2%, while the accuracy ranged from 92.7 to 108.1%. The validated LC–MS–MS method was successfully applied for the determination of atorvastatin and amlodipine in plasma of hypertensive patients.
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Koh KK, Quon MJ, Han SH, Lee Y, Park JB, Kim SJ, Koh Y, Shin EK (2009) Int J Cardiol. doi:10.1016/j.ijcard.2009.07.002
Jukema JW, van der Hoorn JW (2004) Expert Opin Pharmacother 5:459–468. doi:10.1517/14656566.5.2.459
Sivakumar T, Manavalan R, Muralidharan C, Valliappan K (2007) J Sep Sci 30:3143–3153. doi:10.1002/jssc.200700148
Guengerich FP, Brian WR, Iwasaki M, Sari MA, Bäärnhielm C, Berntsson P (1991) J Med Chem 34:1838–1844. doi:10.1021/jm00110a012
McKeage K, Siddiqui MA (2008) Am J Cardiovasc Drugs 8:51–67. doi:10.2165/0129784-200808010-00007
Jacobsen W, Kuhn B, Soldner A, Kirchner G, Sewing KF, Kollman PA, Benet LZ, Christians U (2000) Drug Metab Dispos 28:1369–1378
Molden E, Skovlund E, Braathen P (2008) Drug Saf 31:587–596. doi:10.2165/00002018-200831070-00004
Wilson SA, Sanford A (2006) Am Fam Physician 73:1067–1068
Zou Q, Zhan Y, Ge Z, Wei P, Ouyang P (2009) Arzneimittelforschung 59:383–391
Ramani AV, Sengupta P, Mullangi R (2009) Biomed Chromatogr 23:615–622. doi:10.1002/bmc.1161
Bhatt J, Singh S, Subbaiah G, Shah B, Kambli S, Ameta S (2007) Biomed Chromatogr 21:169–175. doi:10.1002/bmc.730
Nováková L, Vlcková H, Satínský D, Sadílek P, Solichová D, Bláha M, Bláha V, Solich P (2009) J Chromatogr B Analyt Technol Biomed Life Sci 877:2093–2103. doi:10.1016/j.jchromb.2009.05.052
Nirogi R, Mudigonda K, Kandikere V (2007) J Pharm Biomed Anal 44:379–387. doi:10.1016/j.jpba.2007.02.008
Pilli NR, Inamadugu JK, Mullangi R, Karra VK, Vaidya JR, Seshagiri Rao JV (2010) Biomed Chromatogr. doi:10.1002/bmc.1462
Chung M, Calcagni A, Glue P, Bramson C (2006) J Clin Pharmacol 46:1030–1037. doi:10.1177/0091270006291031
U.S. FDA Guidance for Industry on Bioanalytical Method Validation (2001) (http://www.fda.gov/cder/guidance/index.htm)
Matuszewski BK, Constanzer ML, Chavez-Eng CM (2003) Anal Chem 75:3019–3030. doi:10.1021/ac020361s
Liu YM, Pu HH, Liu GY, Jia JY, Weng LP, Xu RJ, Li GX, Wang W, Zhang MQ, Lu C, Yu C (2010) Clin Ther 32:1396–1407. doi:10.1016/j.clinthera.2010.07.004
Liu Y, Jia J, Liu G, Li S, Lu C, Liu Y, Yu C (2009) Clin Ther 31:777–783. doi:10.1016/j.clinthera.2009.04.013
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Financial support for this work was provided in part by the grant JYY0909 from the School of Medicine of Shanghai Jiao Tong University and Shanghai Sixth People’s Hospital (Shanghai, China).
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Yu, Q., Hu, ZY., Zhu, FY. et al. HPLC–MS–MS for the Simultaneous Determination of Atorvastatin and Amlodipine in Plasma of Hypertensive Patients. Chromatographia 73, 257–262 (2011). https://doi.org/10.1007/s10337-010-1883-4
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DOI: https://doi.org/10.1007/s10337-010-1883-4