A simple and rapid HPLC method was developed and validated for simultaneous determination of two antipsychotic drugs, olanzapine and aripiprazole, in spiked human plasma. Optimization studies were performed using experimental design approach. The most important analysis parameters were selected using fractional factorial design and optimum levels of these parameters were determined with Box-Behnken design. Separation was achieved on a monolithic column (Rp-18, 100-4.6 mm) set at 35°C with a flow rate of 0.8 ml/min. Gradient elution was performed with a mobile phase consisting of phosphate buffer (pH 3.14, 20 mM) and acetonitrile. Retention times of olanzapine and aripiprazole were 2.34 and 6.90 minutes, respectively. The method was linear in the range of 0.125-50.0 µg/ml for olanzapine and 0.500-50.0 µg/ml for aripiprazole. The quantification limits for olanzapine and aripiprazole were found 0.069 and 0.498 µg/ml, respectively. The method was found accurate and precise based on recovery values, which were between 99-102% and relative standard deviations, which were lower than 2%. Robustness of the method and the stability of analytes were also investigated.
___
[1] Konopaske GT, Coyle JT. Schizophrenia. In: Zigmond MJ, Coyle JT, Rowland L. (Eds). Neurobiology of Brain Disorders. Academic Press, San Diego, 2015, pp. 639-654. [CrossRef]
[2] Volk DW, Lewis DA. Schizophreni.In: Rosenberg R, Pascual J. (Eds). Rosenberg's Molecular and Genetic Basis of Neurological and Psychiatric Disease (Fifth Edition). Academic Press, Boston, 2015, pp. 1293-1299. [CrossRef]
[3] Zink M, Englisch S, Meyer-Lindenberg A. Polypharmacy in schizophrenia. Curr Opin Psychiatry. 2010; 23(2): 103- 111. [CrossRef]
[4] Patteet L, Morrens M, Maudens KE, Niemegeers P, Sabbe B, Neels H. Therapeutic drug monitoring of common antipsychotics. Ther Drug Monit. 2012; 34(6): 629-651. [CrossRef]
[5] Duggal HS. Aripirazole—Olanzapine combination for treatment of schizophrenia. Can J Psychiatry. 2004; 49(2): 151. [CrossRef]
[6] Chen CH, Huang MC, Lu ML. Aripiprazole improves metabolic adversity in olanzapine-treated schizophrenic patients. J Clin Psychopharmacol. 2007; 27(5): 516-517. [CrossRef]
[7] Englisch S, Weinbrenner A, Inta D, Zink M. Aripiprazole for the management of olanzapine-induced weight gain. Pharmacopsychiatry. 2009; 42(04): 166-167. [CrossRef]
[8] Henderson DC, Fan X, Copeland PM, Sharma B, Borba CP, Boxill R, Freudenreich O, Cather C, Evins AE, Goff DC. Aripiprazole added to overweight and obese olanzapine-treated schizophrenia patients. J Clin Psychopharmacol. 2009; 29(2): 165-169. [CrossRef]
[9] Schönfelder S, Schirmbeck F, Waltereit R, Englisch S, Zink M. Aripiprazole improves olanzapine-associated obsessive compulsive symptoms in schizophrenia. Clin Neuropharmacol. 2011; 34(6): 256-257. [CrossRef]
[10] Aggarwal H, Kumar P. Aripiprazole for olanzapine-induced symptomatic hyperprolactinemia. Indian J Pharmacol. 2010; 42(1): 57-61. [CrossRef]
[11] Patteet L, Cappelle D, Maudens KE, Crunelle CL, Sabbe B, Neels H. Advances in detection of antipsychotics in biological matrices. Clin Chim Acta. 2015; 441: 11-22. [CrossRef]
[12] Dusci LJ, Peter Hackett L, Fellows LM, Ilett KF. Determination of olanzapine in plasma by high-performance liquid chromatography using ultraviolet absorbance detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2002; 773(2): 191-197. [CrossRef]
[13] Olesen OV, 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. J Chromatogr B Biomed Sci Appl. 1998; 714(2): 309-315. [CrossRef]
[14] Boulton DW, Markowitz JS, DeVane CL. A high-performance liquid chromatography assay with ultraviolet detection for olanzapine in human plasma and urine. J Chromatogr B Biomed Sci Appl. 2001; 759(2): 319-323. [CrossRef]
[15] Musenga A, Saracino MA, Spinelli D, Rizzato E, Boncompagni G, Kenndler E, Raggi MA. Analysis of the recent antipsychotic aripiprazole in human plasma by capillary electrophoresis and high-performance liquid chromatography with diode array detection. Anal Chim Acta. 2008; 612(2): 204-211. [CrossRef]
[16] Lancelin F, Djebrani K, Tabaouti K, Kraoul L, Brovedani S, Paubel P, Piketty ML. Development and validation of a high-performance liquid chromatography method using diode array detection for the simultaneous quantification of aripiprazole and dehydro-aripiprazole in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2008; 867(1): 15-19. [CrossRef]
[17] Shimokawa Y, Akiyama H, Kashiyama E, Koga T, Miyamoto G. High performance liquid chromatographic methods for the determination of aripiprazole with ultraviolet detection in rat plasma and brain: Application to the pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2005; 821(1): 8-14. [CrossRef]
[18] Wang ST, Li Y. Development of a UPLC-MS/MS method for routine therapeutic drug monitoring of aripiprazole, amisulpride, olanzapine, paliperidone and ziprasidone with a discussion of their therapeutic reference ranges for Chinese patients. Biomed Chromatogr. 2017; 31(8): e3928-n/a. [CrossRef]
[19] Kirchherr H, Kühn-Velten WN. Quantitative determination of forty-eight antidepressants and antipsychotics in human serum by HPLC tandem mass spectrometry: A multi-level, single-sample approach. J Chromatogr B Analyt Technol Biomed Life Sci. 2006; 843(1): 100-113. [CrossRef]
[20] Choong E, Rudaz S, Kottelat A, Guillarme D, Veuthey JL, Eap CB. Therapeutic drug monitoring of seven psychotropic drugs and four metabolites in human plasma by HPLC–MS. J Pharm Biomed Anal. 2009; 50(5): 1000- 1008. [CrossRef]
[21] Uřinovská R, Brozmanová H, Šištík P, Šilhán P, Kacířová I, Lemr K, Grundmann M. Liquid chromatography– tandem mass spectrometry method for determination of five antidepressants and four atypical antipsychotics and their main metabolites in human serum. J Chromatogr B Analyt Technol Biomed Life Sci. 2012; 907: 101-107. [CrossRef]
[22] Patteet L, Maudens KE, Sabbe B, Morrens M, De Doncker M, Neels H. High throughput identification and quantification of 16 antipsychotics and 8 major metabolites in serum using ultra-high performance liquid chromatography–tandem mass spectrometry. Clin Chim Acta. 2014; 429: 51-58. [CrossRef]
[23] Hibbert DB. Experimental design in chromatography: A tutorial review. J Chromatogr B. 2012; 910: 2-13. [CrossRef]
[24] Sahu PK, Ramisetti NR, Cecchi T, Swain S, Patro CS, Panda J. An overview of experimental designs in HPLC method development and validation. J Pharm Biomed Anal. 2018; 147: 590-611. [CrossRef]
[25] The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Validation of analytical procedures: text and methodology, Q2(R1). Harmonized Tripartite Guideline. 2005.
[26] Jancic-Stojanovic B, Malenovic A, Ivanovic D, Rakic T, Medenica M. Chemometrical evaluation of ropinirole and its impurity's chromatographic behavior. J Chromatogr A. 2009; 1216(8): 1263-1269. [CrossRef]