High Performance Liquid Chromatography Mass Spectrometric Method for the Simultaneous Quantification of Pravastatin and Aspirin in Human Plasma: Pharmacokinetic Application

Overview

Journal J Pharm Anal

Specialty Chemistry

Date 2018 Feb 7

PMID 29403744

Citations 6

Authors

Srinivasa Rao Polagani

Nageswara Rao Pilli

Venkateswarlu Gandu

Affiliations

Soon will be listed here.

Abstract

A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for the simultaneous quantification of pravastatin and aspirin in human plasma. Furosemide was used as an internal standard. Analytes and the internal standard were extracted from human plasma by liquid-liquid extraction technique using methyl tertiary butyl ether. The reconstituted samples were chromatographed on a Zorbax SB-C column by using a mixture of 5 mM ammonium acetate buffer and acetonitrile (20:80, v/v) as the mobile phase at a flow rate of 0.8 mL/min. The calibration curve obtained was linear (≥0.99) over the concentration range of 0.50-600.29 ng/mL for pravastatin and 20.07-2012.00 ng/mL for aspirin. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.0 min for each sample made it possible to analyze more than 400 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

Citing Articles

Detection of Pharmaceutical Contamination in Amphipods of Lake Baikal by the HPLC-MS Method.

Telnova T, Morgunova M, Shashkina S, Vlasova A, Dmitrieva M, Shelkovnikova V Antibiotics (Basel). 2024; 13(8).

PMID: 39200038 PMC: 11350909. DOI: 10.3390/antibiotics13080738.

An overview of three biocatalysts of pharmaceutical importance synthesized by microbial cultures.

Dahiya D, Nigam P AIMS Microbiol. 2021; 7(2):124-137.

PMID: 34250371 PMC: 8255904. DOI: 10.3934/microbiol.2021009.

Application of LC-MS/MS for quantitative analysis of glucocorticoids and stimulants in biological fluids.

Haneef J, Shaharyar M, Husain A, Rashid M, Mishra R, Parveen S J Pharm Anal. 2018; 3(5):341-348.

PMID: 29403837 PMC: 5760999. DOI: 10.1016/j.jpha.2013.03.005.

Simultaneous determination of atorvastatin, metformin and glimepiride in human plasma by LC-MS/MS and its application to a human pharmacokinetic study.

Rao Polagani S, Pilli N, Gajula R, Gandu V J Pharm Anal. 2018; 3(1):9-19.

PMID: 29403791 PMC: 5760920. DOI: 10.1016/j.jpha.2012.09.002.

Quantitative determination of pravastatin and its metabolite 3α-hydroxy pravastatin in plasma and urine of pregnant patients by LC-MS/MS.

Zhang X, Vernikovskaya D, Wang X, Nanovskaya T, Costantine M, Hankins G Biomed Chromatogr. 2015; 30(4):548-54.

PMID: 26360932 PMC: 4744801. DOI: 10.1002/bmc.3581.

References

Jain K, Kathiravan M, Somani R, Shishoo C . The biology and chemistry of hyperlipidemia. Bioorg Med Chem. 2007; 15(14):4674-99. DOI: 10.1016/j.bmc.2007.04.031. View

Sueta C, Chowdhury M, Boccuzzi S, Smith Jr S, Alexander C, Londhe A . Analysis of the degree of undertreatment of hyperlipidemia and congestive heart failure secondary to coronary artery disease. Am J Cardiol. 1999; 83(9):1303-7. DOI: 10.1016/s0002-9149(99)00117-4. View

Hatanaka T . Clinical pharmacokinetics of pravastatin: mechanisms of pharmacokinetic events. Clin Pharmacokinet. 2001; 39(6):397-412. DOI: 10.2165/00003088-200039060-00002. View

Tsikas D, Tewes K, Gutzki F, Schwedhelm E, Greipel J, Frolich J . Gas chromatographic-tandem mass spectrometric determination of acetylsalicylic acid in human plasma after oral administration of low-dose aspirin and guaimesal. J Chromatogr B Biomed Sci Appl. 1998; 709(1):79-88. DOI: 10.1016/s0378-4347(98)00049-8. View

. Prevention of coronary heart disease in clinical practice. Recommendations of the Second Joint Task Force of European and other Societies on coronary prevention. Eur Heart J. 1998; 19(10):1434-503. DOI: 10.1053/euhj.1998.1243. View

Burch J, Stanford N, MAJERUS P . Inhibition of platelet prostaglandin synthetase by oral aspirin. J Clin Invest. 1978; 61(2):314-9. PMC: 372541. DOI: 10.1172/JCI108941. View

Lennernas H, Fager G . Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Similarities and differences. Clin Pharmacokinet. 1997; 32(5):403-25. DOI: 10.2165/00003088-199732050-00005. View

Kawabata K, Samata N, Urasaki Y . Quantitative determination of pravastatin and R-416, its main metabolite in human plasma, by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2005; 816(1-2):73-9. DOI: 10.1016/j.jchromb.2004.11.014. View

Xu X, Koetzner L, Boulet J, Maselli H, Beyenhof J, Grover G . Rapid and sensitive determination of acetylsalicylic acid and salicylic acid in plasma using liquid chromatography-tandem mass spectrometry: application to pharmacokinetic study. Biomed Chromatogr. 2009; 23(9):973-9. DOI: 10.1002/bmc.1209. View

10.

Caslavska J, Thormann W . Rapid analysis of furosemide in human urine by capillary electrophoresis with laser-induced fluorescence and electrospray ionization-ion trap mass spectrometric detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 770(1-2):207-16. DOI: 10.1016/s0378-4347(01)00560-6. View

11.

Quion J, Jones P . Clinical pharmacokinetics of pravastatin. Clin Pharmacokinet. 1994; 27(2):94-103. DOI: 10.2165/00003088-199427020-00002. View

12.

Corsini A, Bellosta S, Baetta R, Fumagalli R, Paoletti R, Bernini F . New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol Ther. 2000; 84(3):413-28. DOI: 10.1016/s0163-7258(99)00045-5. View

13.

Davidson M, Toth P . Comparative effects of lipid-lowering therapies. Prog Cardiovasc Dis. 2004; 47(2):73-104. DOI: 10.1016/j.pcad.2004.04.007. View

14.

PEARSON T, Laurora I, Chu H, Kafonek S . The lipid treatment assessment project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000; 160(4):459-67. DOI: 10.1001/archinte.160.4.459. View

15.

Zhu Z, Neirinck L . High-performance liquid chromatography coupled with negative ion tandem mass spectrometry for determination of pravastatin in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 783(1):133-40. DOI: 10.1016/s1570-0232(02)00526-3. View

16.

Hennekens C, Sacks F, Tonkin A, Jukema J, Byington R, Pitt B . Additive benefits of pravastatin and aspirin to decrease risks of cardiovascular disease: randomized and observational comparisons of secondary prevention trials and their meta-analyses. Arch Intern Med. 2004; 164(1):40-4. DOI: 10.1001/archinte.164.1.40. View

17.

Triscari J, Swanson B, Willard D, Cohen A, DeVault A, Pan H . Steady state serum concentrations of pravastatin and digoxin when given in combination. Br J Clin Pharmacol. 1993; 36(3):263-5. PMC: 1364648. DOI: 10.1111/j.1365-2125.1993.tb04227.x. View

18.

Dagli N, Yavuzkir M, Karaca I . The effects of high dose pravastatin and low dose pravastatin and ezetimibe combination therapy on lipid, glucose metabolism and inflammation. Inflammation. 2007; 30(6):230-5. DOI: 10.1007/s10753-007-9041-3. View

19.

De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J . European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003; 24(17):1601-10. DOI: 10.1016/s0195-668x(03)00347-6. View