Simultaneous quantification of atorvastatin and active metabolites in human plasma by liquid chromatography-tandem mass spectrometry using rosuvastatin as internal standard

Biomedical Chromatography

Volumn 20, Issue 9, 2006, Pages 924-936

  Nirogi, Ramakrishna V S ^a   Kandikere, Vishwottam N ^a   Shukla, Manoj ^a   Mudigonda, Koteshwara ^a   Maurya, Santosh ^a   Boosi, Ravikumar ^a   Anjaneyulu, Yerramilli ^b  

^a SUVEN LIFE SCIENCES LTD   (India)

^b JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY   (India)

Author keywords

Atorvastatin; LC MS MS; Metabolites; Pharmacokinetic study

Indexed keywords

BIOCHEMISTRY; BIOMOLECULES; MASS SPECTROMETRY; PHARMACOKINETICS; PLASMA (HUMAN);

ACTIVE METABOLITES; ATORVASTATIN; HUMAN PLASMA SAMPLES; HUMAN PLASMAS; INTERNAL STANDARDS; LC-MS-MS; LC.MS/MS; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY; PHARMACOKINETIC STUDIES;

METABOLITES;

2 HYDROXYATORVASTATIN; 4 HYDROXYATORVASTATIN; ATORVASTATIN; DRUG METABOLITE; ROSUVASTATIN; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CHEMICAL REACTION; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG STRUCTURE; HUMAN; LIQUID CHROMATOGRAPHY; LIQUID LIQUID EXTRACTION; QUANTITATIVE ANALYSIS; SENSITIVITY ANALYSIS; SEPARATION TECHNIQUE; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

EID: 33748942492     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.622     Document Type: Article

References (36)

1. Bakker-Arkema RG, Davidson MH, Goldstein RJ, Davignon J, Isaacsohn JL, Weiss SR, Keilson LM, Brown WV, Miller VT, Shurzinske LJ and Black DM. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. Journal of American Medical Association 1996; 275: 128.
2. Bullen WW, Miller RA and Hayes RN. Development and validation of a high-performance liquid chromatography tandem mass spectrometry assay for atorvastatin, ortho-hydroxyatorvastatin, and para-hydroxyatorvastatin in human, dog and rat plasma. American Society for Mass Spectrometry 1999; 10: 55.
3. Chong PH, Seeger JD and Franklin C. Clinically relevant differences between the statins: implications for therapeutic selection. American Journal of Medicine 2001; 111: 390.
4. Cilla DD Jr, Whitfield LR, Gibson DM, Sedman AJ and Posvar EL. Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clinical Pharmacology and Therapeutics 1996; 60: 687.
5. Gibson DM, Bron NJ, Richens A, Hounslow NJ, Sedman AJ and Whitfield LR. Effect of age and gender on pharmacokinetics of atorvastatin in humans. Journal of Clinical Pharmacology 1996; 36: 242.
6. Guerin M, Egger P, Soudant C, Le Goff W, van Tol A, Dupuis R and Chapman MJ. Dose-dependent action of atorvastatin in type IIB hyperlipidemia: preferential and progressive reduction of atherogenic apoB-containing lipoprotein subclasses (VLDL-2, IDL, small dense LDL) and stimulation of cellular cholesterol efflux. Atherosclerosis 2002; 163: 287.
7. Hermann M, Christensen H and Reubsaet JL. Determination of atorvastatin and metabolites in human plasma with solid-phase extraction followed by LC-tandem MS. Analytical and Bioanalytical Chemistry 2005; 382: 1242.
8. Jacobsen W, Kuhn B, Soldner A, Kirchner G, Sewing KF, Kollman PA, Benet LZ and Christians U. Lactonization is the critical first step in the disposition of the 3-hydroxy-3-methylgutaryl-CoA reductase inhibitor atorvastatin. Drug Metabolism and Disposition 2000; 28: 1369.
9. Jemal M. High throughput quantitative bioanalysis by LC-MS/MS. Biomedical Chromatography 2000; 14: 422.
10. Jemal M, Ouyang Z, Chen B and Teitz D. Quantitation of the acid and lactone forms of atorvastatin and its biotransformation products in human serum by high-performance liquid chromatography with electrospray tandem mass spectrometry. Rapid Communications in Mass Spectrometry 1999; 13: 1003.
11. Jones P, Kafonek S, Laurora I and Hunninghake D. Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). American Journal of Cardiology 1998; 81: 582.
12. Kantola T, Kivisto K and Neuvonen P. Effect of itraconazole on the pharmacokinetics of atorvastatin. Clinical Pharmacology and Therapeutics 1998; 64: 58.
13. Koytchev R, Ozalp Y, Erenmemisoglu A, van der Meer M and Alpan RS. Bioequivalence study of atorvastatin tablets. Arzneimittelforschung/Drug Research 2004; 54: 573.
14. Lins RL, Matthys KE, Verpooten GA, Peeters PC, Dratwa M, Stolear J and Lameire NH. Pharmacokinetics of atorvastatin and its metabolites after single and multiple dosing in hypercholesterolaemic haemodialysis patients. Nephrology, Dialysis and Transplantation 2003; 18: 967.
15. Nawrocki JW, Weiss SR, Davidson MH, Sprecher DL, Schwartz SL, Lupien PJ, Jones PH, Haber HE and Black DM. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arteriosclerosis, Thrombosis and Vascular Biology 1995; 15: 678.
16. Niessen WM. Progress in liquid chromatography-mass spectrometry instrumentation and its impact on high-throughput screening. Journal of Chromatography A 2003; 1000: 413.
17. Nirogi RVS, Kandikere VN, Shukla M., Mudigonda K, Maurya S, Boosi R and Yerramilli A. Sensitive and selective liquid chromatography/tandem mass spectrometry method for the quantification of azithromycin in human plasma. Analytica Chimica Acta 2005a; DOI: 10.1016/j.aca.2005.08.007.
18. Nirogi RVS, Kandikere VN, Shukla M., Mudigonda K, Maurya S, Boosi R and Yerramilli A. Liquid chromatographic tandem mass spectrometry method for the quantification of miglitol in human plasma. Arzneimittelforschung/ Drug Research 2005b (in press).
19. Parke-Davis. Product information: lipitor (Atorvastatin calcium). Parke-Davis (Division of Pfizer Inc.): Ann Arbor, MI, 2004.
20. Posvar EL, Radulovic LL, Cilla DD, Whitfield LR and Sedman AJ. Tolerance and pharmacokinetics of single-dose atorvastatin, a potent inhibitor of HMG-CoA reductase, in healthy subjects. Journal of Clinical Pharmacology 1996; 36: 728.
21. Radulovic LL, Cilla DD, Posvar EL, Sedman AJ and Whitfield LR. Effect of food on the bioavailability of atorvastatin, an HMG-CoA reductase inhibitor. Journal of Clinical Pharmacology 1995; 35: 990.
22. Ramakrishna NVS, Koteshwara M, Vishwottam KN, Puran S, Manoj S and Santosh M. Simple, sensitive and rapid LC-MS/MS method for the quantitation of cerivastatin in human plasma - application to pharmacokinetic studies. Journal of Pharmaceutical and Biomedical Analysis 2004a; 36: 505.
23. Ramakrishna NVS, Vishwottam KN, Puran S, Koteshwara M, Manoj S and Santosh M. Selective and rapid liquid chromatography-tandem mass spectrometry assay of dutasteride in human plasma. Journal of Chromatography B 2004b; 809: 117.
24. Ramakrishna NVS, Vishwottam KN, Puran S, Koteshwara M, Manoj S and Santosh M. Quantitation of tadalafil in human plasma by liquid chromatography-tandem mass spectrometry with electro-spray ionization. Journal of Chromatography B 2004c; 809: 243.
25. Ramakrishna NVS, Vishwottam KN, Puran S, Manoj S, Santosh M and Koteshwara M. Simple, sensitive and rapid liquid chromatography/ electrospray ionization tandem mass spectrometric method for the quantification of lacidipine in human plasma. Journal of Mass Spectrometry 2004d; 39: 824.
26. Ramakrishna NVS, Vishwottam KN, Puran S, Manoj S, Santosh M, Wishu S and Koteshwara M. Liquid chromatography-negative ion electrospray tandem mass spectrometry method for the quantification of tacrolimus in human plasma and its bioanalytical applications. Journal of Chromatography B 2004e; 805: 13.
27. Ramakrishna NVS, Vishwottam KN, Manoj S, Koteshwara M, Chidambara J and Varma DP. Validation and application of a high-performance liquid chromatography-tandem mass spectrometry assay for mosapride in human plasma. Biomedical Chromatography 2005a; 19: 539.
28. Ramakrishna NVS, Vishwottam KN, Koteshwara M, Manoj S, Santosh M and Varma DP. Rapid quantification of nebivolol in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 2005b; 39: 1006.
29. Ramakrishna NVS, Vishwottam KN, Manoj S, Koteshwara M, Wishu S and Varma DP. Rapid, simple and highly sensitive LC-ESI-MS/MS method for the quantification of tamsulosin in human plasma. Biomedical Chromatography 2005c; 19: 709.
30. Ramakrishna NVS, Vishwottam KN, Manoj S, Koteshwara M, Wishu S and Varma DP. Sensitive liquid chromatography-tandem mass spectrometry method for quantification of hydrochlorothiazide in human plasma. Biomedical Chromatography 2005d; 19: 751.
31. Ramakrishna NVS, Vishwottam KN, Koteshwara M, Manoj S, Santosh M, Chidambara J, Sumatha B and Varma DP. Rapid quantification of gabapentin in human plasma by liquid chromatography/tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 2005e; DOI: 10.1016/ j.jpba.2005.07.012.
32. Ramakrishna NVS, Vishwottam KN, Manoj S, Koteshwara M, Santosh M, Chidambara J and Kumar BR. Liquid chromatography/electrospray ionization mass spectrometry method for the quantification of valproic acid in human plasma. Rapid Communications in Mass Spectrometry 2005f; 19: 1970.
33. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report. European Journal of Drug Metabolism and Pharmacokinetics 1991; 16: 249.
34. Shumm YY, Huang N, Walter G, Black A, Sekerke C, Chang T and Whitfield LR. Development, validation, and intralaboratory comparison of an HMG-CoA reductase inhibition assay for quantitation of atorvastatin in plasma matrices. Therapeutic Drug Monitoring 1998; 20: 41.
35. Siedlik PH, Olson SC, Yang BB and Stern RH. Erythromycin coadministration increases plasma atorvastatin concentrations. Journal of Clinical Pharmacology 1999; 39: 501.
36. Zarghi A, Shafaati A, Foroutan S and Khoddam A. A simple and rapid HPLC method for the determination of atorvastatin in human plasma with UV detection and its application to pharmacokinetic studies. Arzneimittelforschung/Drug Research 2005; 55: 451.