Mevlut ALBAYRAK, Yucel KADİOGLU, Bilal YİLMAZ

Determination of Olanzapine in Pharmaceutical Preparations by Linear Sweep Voltammetry Method

In this study, simple and fast linear sweep voltammetry method was developed and validated for determination of olanzapine in pharmaceutical preparations. The proposed method was based on electrochemical oxidation of olanzapine on glassy carbon electrode in solution containing 0.04 M BrittonRobinson buffer of pH 1.65. The well-defined an oxidation peak was observed at 1.06 V. The calibration curve was linear for olanzapine at the concentration range of 2.5-50 µg/mL for linear sweep voltammetry method. Intra- and inter-day precision values for olanzapine were less than 4.78, and accuracy (relative error) was better than 1.85%. The limits of detection and quantification of olanzapine were 0.50 and 1.50 µg/mL, respectively. The mean recovery of olanzapine was 99.8% for pharmaceutical preparations. Stability measurements were carried out with linear sweep voltammetry method. The results were evaluated comparing these measurements with those of standards and expressed as percentage deviation and olanzapine was found as stable at room temperature, 4 and -20 °C for at least 72 h. No interference was found excipient at the selected assay conditions. The voltammetric run time of 1 min allows the analysis of a large number of samples in a short period of time. The proposed method is highly sensitive, precise and accurate and can be used for the reliable quantitation of olanzapine in pharmaceutical dosage form

PDF

___

[1] Goodman and Gilman’s. The Pharmacological Basis of Therapeutics, Eds.; 9th Ed.; Hardman, J.G.; Limbird, L.E.; Eds.; The McGraw-Hill Companies: 1996.
[2] Aravagari, M.; Ames, D.; Wirshing, W.C.; Marder, S.R. Plasma level monitoring of olanzapine in patients with schizophrenia: determination by high performance liquid chromatography with electrochemical detection. Therapeutic Drug Monitoring. 1997; 19, 307-313.
[3] Catlow, J.T.; Barton, R.D.; Clemens, M.; Gillespie, T.A.; Goodwin, M.; Swanson, S.P. Analysis of olanzapine in human plasma utilizing reversed-phase high-performance liquid chromatography with electrochemical detection. Journal of Chromatography B. 1995; 668, 85-90.
[4] Chiu, J.A., Franklin, R.B. Analysis and pharmacokinetics of olanzapine (LY 170053) and two metabolites in rat plasma using reversed-phase HPLC with electrochemical detection. Journal of Pharmaceutical and Biomedical Analysis. 1996; 14, 609-615.
[5] Kasper, S.C.; Mattiuz, E.L.; Swanson, S.P.; Chiu, J.A.; Johnson, J.T.; Garner, C.O. Deter-mination of olanzapine in human breast milk by high-performance liquid chromatography with electrochemical detection. Journal of Chromatography B: Biomedical Sciences and Applications. 1999; 726, 203-209.
[6] Dusci, L.J.; Peter-Hackett, L.; Fellows, L.M.; Ilett, K.F. Determination of olanzapine in plasma by high-performance liquid chromatography using ultraviolet absorbance detection. Journal of Chromatography B. 2002; 773, 191-197.
[7] Olesen, O.V.; Linnet, K. Determination of olanzapine in serum by high performance liquid chromatography using ultraviolet detection considering the easy oxidability of the compound and the presence of other psychotropic drugs. Journal of Chromatography B. 1998; 714, 309-315.
[8] Boulton, D.W.; Markowitz, J.S.; DeVane, C.L. A highperformance liquid chromatography assay with ultraviolet detection for olanzapine in human plasma and urine. Journal of Chromatography B. 2001; 759, 319-323.
[9] Raggi, M.A.; Casamenti, G.; Mandrioli, R.; Fanali, S.; Ronchi, D.D.; Volterra, V. Determination of the novel antipsychotic drug olanzapine in human plasma using HPLC with amperometric detection. Chromatographia. 2000; 51, 562-566.
[10] Berna, M.; Shugert, R.; Mullen, J. Determination of olanzapine in human plasma and serum by liquid chromatography/tandem mass spectrometry. Journal of Mass Spectrometry. 1998; 33, 1003-1008.
[11] Berna, M.; Ackermann, B.; Ruterbories, K.; Glass, S. Determination of olanzapine in human blood by liquid chromatography/tandem mass spectrometry. Journal of Chromatography B. 2002; 767, 163-168.
[12] Murphy, A.T.; Lake, B.G.; Bernstein, J.R.; Franklin, R.B.; Gillespie, T.A. Characterization of olanzapine (LY170053) in human liver slices by liquid chromatography mass spectrometry Journal of Mass Spectrometry. 1998; 33, 1237- 1245.
[13] Bogusz, M.J.; Krueger, K.D.; Maier, R.D.; Erkwoh, R.; Tuchtenhagen, F. Monitoring of olanzapine in serum by liquid chromatography atmospheric pressure chemical ionization mass spectrometry. Journal of Chromatography B: Biomedical Sciences and Applications. 1999; 732, 257-269.
[14] Pucci, V.; Raggi, M.; Kenndler, E. Separation of eleven central nervous system drugs by capillary zone electrophoresis. Journal of Chromatography B: Biomedical Sciences and Applications. 1999; 728, 263-271.
[15] El-Hefnawey, G.B.; El-Hallag, I.S.; Ghoneim, E.M.; Ghoneim, M.M. Voltammetric behavior and quantification of the sedative-hypnotic drug chlordiazepoxide in bulk form, pharmaceutical formulation and human serum at a mercury electrode. Journal of Pharmaceutical and Biomedical Analysis. 2004; 34, 75-86.
[16] Corti, P.; Corbini, G.; Gratteri, P.; Furlanetto, S.; Pinzauti, S. Determination of some quinolones in tablets, human plasma and urine by differential-pulse polarography. International Journal of Pharmaceutics. 1994; 111, 83-87.
[17] Radi, A.; Elmogy, T. Differential pulse voltammetric determination of carvedilol in tablets dosage form using glassy carbon electrode. Farmaco. 2005; 60, 43-46.
[18] Dogan, B.; Ozkan, S.A. Electrochemical behavior of carvedilol and its adsorptive stripping determination in dosage forms and biological fluids. Electroanalysis. 2005; 17, 2074-2083.
[19] Laviron, E.; Roullier, L.; Degrand, C. A multilayer model for the study of space distributed redox modified electrodes: Part II. Theory and application of linear potential sweep voltammetry for a simple reaction. Journal of Electroanalytical Chemistry. 1980; 112, 11-23.
[20] Yilmaz, B.; Ekinci, D. Voltammetric behavior of carvedilol in non-aqueous media and its analytical determination in pharmaceutical preparations. Reviews in Analytical Chemistry. 2011; 30, 187-193.
[21] Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD, 2001.
[22] The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95, 1996.
[23] Biryol, I., Erk, N. Voltammetric, spectrophotometric, and high performance liquid chromatographic analysis of olanzapine. Analytical Letters. 2003; 36, 2497-2513.