Nonlinear calibrations on the assay of dilitiazem and two of its metabolites from plasma samples by means of liquid chromatography and ESI/MS2 detection: Application to a bioequivalence study

Biomedical Chromatography

Volumn 22, Issue 3, 2008, Pages 289-297

  Georgita, Cristina ^a   Albu, Florin ^a   David, Victor ^a   Medvedovici, Andrei ^a,b  

^a LaborMed Pharma SA   (Romania)

^b UNIVERSITY OF BUCHAREST   (Romania)

Author keywords

Bioequivalence; Desacetyldiltiazem; Desmethyldiltiazem; Diltiazem; Fragmentation pattern; Human plasma; LC (ESI)MS2; Method validation; Nonlinear calibration

Indexed keywords

ATMOSPHERIC PRESSURE; DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; METABOLITES; ORGANIC SOLVENTS;

BIOEQUIVALENCE; DESACETYLDILTIAZEM; DESMETHYLDILTIAZEM; DILTIAZEM; FRAGMENTATIONS PATTERN; HUMAN PLASMAS; LC-ESI-MS; LC/(ESI)MS2; LC/ESI-MS; METHOD VALIDATIONS; NONLINEAR CALIBRATION;

ELECTROSPRAY IONIZATION;

5 [2 (DIMETHYLAMINO)ETHYL] 2 (4 METHOXYPHENYL) 4 OXO 2,3,4,5 TETRAHYDRO 1,5 BENZOTHIAZEPIN 3 YL; ACETONITRILE; DEACETYLDILTIAZEM; DILTIAZEM; DILTIAZEM DERIVATIVE; DRUG METABOLITE; NORDILTIAZEM; ORGANIC SOLVENT; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CALIBRATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSE REGIMEN; DRUG ELIMINATION; DRUG HALF LIFE; DRUG STRUCTURE; ELECTROSPRAY MASS SPECTROMETRY; ELUTION; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; NORMAL HUMAN; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SEPARATION TECHNIQUE; SINGLE BLIND PROCEDURE; SINGLE DRUG DOSE; VALIDATION PROCESS; VOLUNTEER;

EID: 41549134040     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.927     Document Type: Article

References (19)

1. Ascalone V, Loactelli M and Malavasi B. Determination of diltiazem and its main metabolites in human plasma by automated solid-phase extraction and high-performance liquid chromatography: a new method overcoming instability of the compounds and interference problems. Journal of Chromatography B: Biomedical Sciences and Applications 1994; 657: 133-140.
2. Bruggemann L, Quapp W and Wennrich R. Test for non-linearity concerning linear calibrated chemical measurements. Accreditation and Quality Assurance 2006; 11: 625-631.
3. Carignan G, Carrier K, Laganiere S and Lessard M. Simultaneous determination of diltiazem and quinidine in human plasma by liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications 1995; 672: 261-269.
4. Chankvetadze B, Kartozia I and Blaschke G. Simultaneous enantioseparation of cis-diltiazem hydrochloride and its metabolite cis-desacetyldiltiazem using high-performance liquid chromatography and capillary electrophoresis. Journal of Pharmaceutical and Biomedical Analysis 2002; 27: 161-166.
5. Christensen H, Carlson E, Asberg A, Schram L and Berg KJ. A simple and sensitive high-performance liquid chromatography assay of diltiazem and main metabolites in renal transplanted patients. Clinica Chimica Acta 1999; 283: 63-75.
6. FDA. Guidance for Industry. Bioanalytical Method Validation. US Department of Health and Human Services, FDA, CDER, CVM, 2001; available at: www.fda.gov/cder/guidance/index.htm
7. Frishman WH. A new extended-release formulation of diltiazem HCl for the treatment of mild-to-moderate hypertension. Journal of Clinical Pharmacology 1993; 33: 612-622.
8. Guimont S, Landriault H, Klisher K, Grace M, Lambert C, Caille G, Gossard D, Russell A, Raymond M and Hutchings E. Comparative pharmacokinetics and pharmacodynamics of two marketed bid formulations of diltiazem in healthy volunteers. Biopharmaceutics and Drug Disposition 1993; 14: 767-778.
9. Hoglund PNL. Pharmacokinetics of diltiazem and its metabolites after single and multiple dosing in healthy volunteers. Therapeutic Drug Monitoring 1989; 11: 558-566.
10. Li K, Zhang X and Zhao F. HPLC determination of diltiazem in human plasma and its application to pharmacokinetics in humans. Biomedical Chromatography 2003; 17: 522-525.
11. Molden E, Johansen PW, Boe GH, Bergan S, Christensen H, Rugstad HE, Rootwelt H, Reubsaet L and Lehne G. Pharmacokinetics of diltiazem and its metabolites in relation to CYP2D6 genotype. Clinical Pharmacology and Therapeutics 2002; 72: 333-342.
12. Molden E, Boe GH, Christensen H and Reubsaet L. High-performance liquid chromatography-mass spectrometry analysis of diltiazem and 11 of its phase I metabolites in human plasma. Journal of Pharmaceutical and Biomedical Analysis 2003; 33: 275-285.
13. Paczkowski D, Dabrowski R, Sitkiewicz D and Sadowski Z. Analysis of diltiazem and desacetyldiltiazem in serum by high-performance liquid chromatography. Polish Journal of Pharmacology 1995; 47: 429-434.
14. Parissi-Poulou M, Ismailos G and Macheras P. Modified HPLC analysis of diltiazem in plasma for pharmacokinetic studies. International Journal of Pharmaceutics 1990; 62: R13-R16.
15. Pichard L, Gillet G, Fabre I, Dalet-Beluche I, Bonfils C, Tenot JP and Maurel P. Identification of the rabbit and human cytochromes P-450IIIA as the major enzymes involved in the N-demethylation of diltiazem. Drug Metabolism and Dispositions 1990; 18: 711-719.
16. Sista S, Lai JCK, Eradiri O and Albert KS. Pharmacokinetics of a novel diltiazem HCl extended-release tablet formulation for evening administration. Journal of Clinical Pharmacology 2003; 43: 1149-1157.
17. Scully P, Meehan E and Kelly JG. High-performance liquid chromatographic assay for diltiazem in small-volume blood specimens and application to pharmacokinetic studies in rats. Journal of Chromatography A 1996; 729: 297-300.
18. Wiens RE, Runser DJ, Lacz JP and Dimmitt DC. Quantitation of diltiazem and desacetyldiltiazem in dog plasma by high-performance liquid chromatography. Journal of Pharmaceutical Sciences 1984; 73: 688-689.
19. Zendelovska D, Stafilov T and Stefova M. High-performance liquid chromatographic determination of diltiazem in human plasma after solid-phase and liquid-liquid extraction. Analytical and Bioanalytical Chemistry 2003; 376: 848-853.