Simultaneous quantitation of rosuvastatin and gemfibrozil in human plasma by high-performance liquid chromatography and its application to a pharmacokinetic study

Biomedical Chromatography

Volumn 20, Issue 11, 2006, Pages 1252-1259

  Vittal, Shivva ^a   Shitut, Nikhil R ^a   Kumar, Thammera Ranjit ^a   Vinu, Menon C A ^a   Muliangi, Ramesh ^a   Srinivas, Nuggehally R ^a  

^a DR REDDY'S LABORATORIES LTD   (India)

Author keywords

Gemribrozil; HPLC; Human plasma; Method validation; Phamacokinetics; Rats; Rosuvastatin

Indexed keywords

ACETONITRILE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PHARMACOKINETICS; PLASMA (HUMAN); RATS;

CONTROL SAMPLES; GEMFIBROZILS; GEMRIBROZIL; HPLC; HUMAN PLASMAS; INTERNAL STANDARDS; MEASUREMENTS OF; METHOD VALIDATIONS; PHAMACOKINETIC; ROSUVASTATIN;

QUALITY CONTROL;

ACETONITRILE; AMMONIUM ACETATE; CELECOXIB; GEMFIBROZIL; METHANOL; ROSUVASTATIN;

ACCURACY; ANALYTIC METHOD; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG STABILITY; DRUG STRUCTURE; EVAPORATION; FREEZE THAWING; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LINEAR SYSTEM; MALE; NONHUMAN; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RAT; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; SEPARATION TECHNIQUE; SINGLE DRUG DOSE; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

EID: 33751074910     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.692     Document Type: Article

References (22)

1. Benkone Markus S, Klebovich I, Drabant S, Csorgo M, Grezal G and Urmos I. Bioanalysis of gemfibrozil. Comparative human pharmacokinetics of 300 mg of gemfibrozil containing Innogem and Lopid capsules. Acta Pharmaeutica Hungarica 1996; 66: 203-212.
2. Borges NC, Mendes GD, Barrientos-Astigarraga RE, Zappi E, Mendes FD and De Nucci G. Comparative bioavailability study with two gemfibrozil tablet formulations in healthy volunteers. Arzneimittelforschung 2005; 55: 382-386.
3. Davidson M, Ma P, Stein EA, Gotto Jr AM, Raza A, Chitra R and Hutchinson H. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia. American Journal of Cardiology 2002; 89: 268-275.
4. Dix KJ, Coleman DP and Jeffcoat AR. Comparative metabolism and disposition of gemfibrozil in male and female Sprague-Dawley rats and Syrian golden hamsters. Drug Metabolism and Disposition 1999; 27: 138-146.
5. Forland SC, Chaplin L and Cutler RE. Assay of gemfibrozil in plasma by "high-performance" liquid chromatography. Clinical Chemistry 1987; 33: 1938.
6. Gibaldi M and Perrier D. Pharmacokinetics, Swarbrick J. (ed.). Marcel Dekker: New York, 1982; 409.
7. Gonzalez-Penas E, Agarraberes S, Lopez-Ocariz A, Garcia-Quetglas E, Campanero MA, Carballal JJ and Honorato J. A sensitive method for the determination of gemfibrozil in human plasma samples by RP-LC. Journal of Pharmaceutical and Biomedical Analysis 2001; 26: 7-14.
8. Hengy H and Kolle EU. Determination of gemfibrozil in plasma by high performance liquid chromatography. Arzneimittelforschung 1985; 35: 1637-1639.
9. Hermening A, Grafe AK, Baktir G, Mutschler E and Span-Langguth H. Gemfibrozil and its oxidative metabolites: quantification of aglycones, acyl glucuronides, and covalent adducts in samples from preclinical and clinical kinetic studies. Journal of Chromatography B 2000; 741: 129-144.
10. Hull CK, Pennman AD, Smith CK and Martin PD. Quantification of rosuvastatin in human plasma by automated solid-phase extraction using tandem mass spectrometric detection. Journal of Chromatography B 2002; 772: 219-228.
11. Kim MS, Liu DQ, Strauss JR, Capodanno I, Yao Z, Fenyk-Melody JE, Franklin RB and Vincent SH. Metabolism and disposition of gemfibrozil in Wistar and multidrug resistance-associated protein 2-deficient TR-rats. Xenobiotica 2003; 33: 1027-1042.
12. Knauf H, Kolle EU and Mutschler E. Gemfibrozil absorption and elimination in kidney and liver disease. Klinische Wochenschrift 1990; 68: 692-698.
13. Kumar TR, Shitut NR, Kumar PK, Vinu MC, Kumar VV, Mullangi R and Srinivas NR. Determination of rosuvastatin in rat plasma by HPLC: validation and its application to pharmacokinetic studies. Biomedical Chromatography 2006 (in press).
14. Nakagawa A, Shigeta A, Iwabuchi H, Horiguchi M, Nakamura K and Takahagi H. Simultaneous determination of gemfibrozil and its metabolites in plasma and urine by a fully automated high performance liquid chromatographic system. Biomedical Chromatography 1991; 5: 68-73.
15. Olsson AG, Pears J, McKellar J, Mizan J and Raza A. Effect of rosuvastatin on low-density lipoprotein cholesterol in patients with hypercholesterolemia. American Journal of Cardiology 2001; 88: 504-508.
16. Paoletti R, Fahmy M, Mahla G, Mizan J and Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. Journal of Cardiovascular Risk 2001; 8: 383-390.
17. Sallustio BC and Fairchild BA. Biosynthesis, characetrisation and direct high-performance liquid chromatographic analysis of gemfirbrozil 1-O-beta-acylglucuronide. Journal of Chromatography B 1995; 665: 345-353.
18. Schneck DW, Birmingham BK, Zalikowski JA, Mitchell PD, Wang Y, Martin PD, Lasseter KC, Brown CD, Windass AS and Raza A. The effect of gemfibrozil on the pharmacockinetics of rosuvastatin. Clinical Pharmacology and Therapeutics 2004; 75: 455-463.
19. Shah VP, Midha KK, Dighe S, Mcgliveray, IJ, Skelly JP, Jacobi TA, Layoff, T, Viswanathan CT, Cook, CE, McDowall RD, Pittman KA and Spector S. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Journal of Pharmaceutical Sciences 1992; 81: 309-312.
20. Smith CM and Reynard AM. Textbook of Pharmacology. WB Saunders: Philadelphia, PA, 1992; 608.
21. Trivedi RK, Kallem RR, Mullangi R and Srinivas NR. Simultaneous determination of rosuvastatin and fenofibric acid in human plasma by LC-MS/MS with electrospray ionization: assay development, validation and application to a clinical study. Journal of Pharmaceutical and Biomedical Analysis 2005; 39: 661-669.
22. United States Pharmacopoeia. United States Pharmacopoeial Convention: Rockville, MD, 1995; 1982.