Using Chemometrics Methods for Determination of Aripiprazole and Quetiapine as Antipsychotic Drugs in Pharmaceutical Mixture and Biological Fluid by Spectrophotometry Method Based on Continuous Wavelet Transform and Multivariate Calibration

Document Type : Research Article

Authors

Department of Chemistry, North Tehran Branch, Islamic Azad University, Tehran, I.R. IRAN

Abstract

In this study, two multivariate calibration methods, including partial least squares (PLS) and principal component regression (PCR), as well as continuous wavelet transform (CWT) along with spectrophotometry technique were developed for the simultaneous analysis of Aripiprazole (ARI) and Quetiapine (QTP) in the pharmaceutical formulation and biological fluid. The linear range of ARI and QTP was 1-3 and 2-10 μg/mL, respectively for the proposed methods. The root means square error (RMSE) of ARI and QTP related to the test set was obtained 0.014, 0.0758, and 0.194, 0.882 for PLS and PCR methods, respectively. Also, the mean recovery of ARI and QTP was 99.95, 100.04%, and 97.38, 98.83% for PLS and PCR models, respectively. Among various families of wavelets in CWT technique, the Coiflet (Coif3) and Symlet (Sym2) families were selected to determine the value of ARI and QTP, respectively. In this method, the Limit of Detection (LOD) and Limit of Quantification (LOQ) values was found 0.0033, 0.0200, 0.2764, 0.3486 μg/mL for ARI and QTP, respectively. The mean recovery values of ARI and QTP in synthetic mixtures for CWT approach were 96.98%, 98.94%, respectively. A one-way analysis of variance (ANOVA) test was applied to compare the results of both mentioned chemometrics models and High-Performance Liquid Chromatography (HPLC) as a reference method. No significant difference was observed between these methods.

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[1] Reutfors J., Cesta C.E., Cohen J.M., Bateman T., Brauer R., Einarsdóttir K., Engeland A., Furu K., Gissler M., Havard A., Hernandez-Diaz S., Huybrechts K.F., Karlstad Q., Leinonen M.K., Li J., Man K., Pazzagli L., Schaffer A., Schink T., Wang Z., Yu Y., Zoega H., Bröms G, Antipsychotic Drug Use in Pregnancy: A Multinational Study from Ten Countries, Schizophrenia Research, 220: 106-115 (2020).
[2] Gardner D.M., Baldessarini R.J., Waraich P., Modern Antipsychotic Drugs: A Critical Overview, Canadian Medical Association Journal, 172: 1703-1711 (2005).
[3] Coelho da Silva D.G., Sales Kanazawa L.K., Dalla Vecchia D., Schizophrenia: Effects of Aripiprazole in Metabolic Syndrome, Brazilian Journal of Pharmaceutical Sciences, 55: e17840 (2019).
[4] Hana X., Shan X., Du Y., Pang S., Hu L., Development and Evaluation of Novel Innovative Multi-Channel Aripiprazole Orally Disintegrating Tablets, Journal of Drug Delivery Science and Technology, 55: 101446 (2020).
[6] Bruijnzeel D., Suryadevara U., Tandon R., Antipsychotic Treatment of Schizophrenia: An Update, Asian Journal of Psychiatry, 11: 3-7 (2014).
[7] Abdelwahab N.S., Ahmed A.B., Omar M.A., Derayea S.M., Abdelrahman M.M., Green Chromatographic Methods for Simultaneous Determination of Quetiapine and the Co-Administrated Paroxetine in Rat Plasma with Application to Pharmacokinetic Study, Microchemical Journal, 152: 104317 (2020).
[8] Soeiro‑de‑Souza M.G., Videira Dias V., Missio G., Balanza‑Martinez V.., Valiengo L, Carvalho A.F., Alberto Moreno R., Role of Quetiapine Beyond its Clinical Efficacy in Bipolar Disorder: from Neuroprotection to the Treatment of Psychiatric Disorders (Review), Experimental and Therapeutic Medicine, 9: 643-652 (2015).
[9] Wu Z.Y., Huang S., Zou J., Wang Q., Naveed M., Bao H., Wang W., Fukunaga K ., Han F, Autism Spectrum Disorder (ASD): Disturbance of the Melatonin System and its Implications, Biomedicine & Pharmacotherapy, 130: 110496 (2020).
[10] Tural Hesapcioglu S., Ceylan M.F., Kasak M., Pınar Sen C., Olanzapine, Risperidone, and Aripiprazole Use in Children and Adolescents with Autism Spectrum Disorders, Research in Autism Spectrum Disorders, 72: 101520 (2020).
[11] Eldidamony A.M., Hafeez S.M., Abdel Hafez M.M., Spectrophotometric Determination of Aripiprazole, Clozapine and Sulpiride by Ion- Pair Extractionin Precision of the HPLC in Tablets and Biological Fluids, International Journal of Pharmacy and Pharmaceutical Sciences, 7: 178-184 (2015).
[12] Song M, Xu X, Hang T, Wen A, Yang L, Development of an LC–MS/MS Method for the Simultaneous Quantification of Aripiprazole and Dehydroaripiprazole in Human Plasma, Analytical Biochemistry, 385: 270-277 (2009).
[14] Derayea S.M., Ahmed A.B., Abdelwahab N.S., Abdelrahman M.M., Omar M.A., Innovative Spectrofluorometric Protocol Based on Micro-Environment Improvement for Determination of Quetiapine in Dosage Forms and Rat Plasma, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 233: 118196 (2020).
[15] Vignali C., Freni F., Magnani C., Moretti M., Siodambro C., Groppi A., Maria Osculati A.M., Morini L., Distribution of Quetiapine and Metabolites in Biological Fluids and Tissues, Forensic Science International, 307: 110108 (2020).
[16] Posey D.J., Stigler K.A., Erickson C.A., McDougle C.J., Antipsychotics in the Treatment of Autism, The Journal of Clinical Investigation, 118: 6-14 (2008).
[17] Li M., Zhang S., Shi A., Qi W., Liu Y., Determination of Quetiapine in Human Plasma by LC–MS/MS and its Application in a Bioequivalence Study, Journal of Chromatography B, 1060: 10–14 (2017).
[18] Atilakaraca S., Yeniceli Ugur D., Development of a Validated HPLC Method for Simultaneous Determination of Olanzapine and Aripiprazole in Human Plasma, Marmara Pharmaceutical Journal, 22: 493-501 (2018).
[23] Chen X., Liang C., Cui L., Le J., Qian Z., Zhang R., Hong Z., Chai Y., A Rapid LC-MS/MS Method for Simultaneous Determination of Quetiapine and Duloxetine in Rat Plasma and its Application to Pharmacokinetic Interaction Study, Journal of Food and Drug Analysis, 27: 323-331 (2019).
[25] Mofavvaz S., Sohrabi M.R., Nezamzadeh-Ejhieh A., New Model for Prediction Binary Mixture of Antihistamine Decongestant Using Artificial Neural Networks and Least Squares Support Vector Machine by Spectrophotometry Method, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 182: 105–115 (2017).
[26] Arabzadeh V., Sohrabi M.R., Goudarzi N., Davallo M., Using Artificial Neural Network and Multivariate Calibration Methods for Simultaneous Spectrophotometric Analysis of Emtricitabine and Tenofovir Alafenamide Fumarate in Pharmaceutical Formulation of HIV Drug, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 215: 266–275 (2019).
[27] Li C.Q., Fang Z., Xu Q.S., A Partition-Based Variable Selection in Partial Least Squares Regression. Chemometrics and Intelligent Laboratory Systems, 198: 103935 (2020).
[28] Naguib I.A., Abdelaleem E.A., Hassan E.S., Ali N.W., Gamal M., Partial Least Squares and Linear Support Vector Regression Chemometric Models for Analysis of Norfloxacin and Tinidazole with Tinidazole Impurity, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 239: 118513 (2020).
[30] Hassaninejad-Darzi S.K., Es’haghi, Z., Zarin S.M., Torkamanzadeh M., Rapid and Simultaneous Determination of Montelukast, Fexofenadine and Cetirizine Using Partial Least Squares and Artificial Neural Networks Modeling, Iran. J. Chem. Chem. Eng. (IJCCE), 36(3): 81-96 (2017).
[32] Sastry B.S., Gananadhamu S., Devalarao G., RP-HPLC Determination of Aripiprazole in Pharmaceutical Formulations. Asian Journal of Chemistry. 21: 6643-6646 (2009).
[33] Belal F., Elbrashy A., Eid M., Jeehan Nasr J., Stability-Indicating HPLC Method for the Determination of Quetiapine: Application to Tablets and Human Plasma, Journal of Liquid Chromatography & Related Technologies, 31: 1283–1298 (2008).
34] Zhao Z., Wang J., Sun B., Arowo M., Shao L., Mass Transfer Study of Water Deoxygenation in a Rotor-Stator Reactor Based on Principal Component Regression Method, Chemical Engineering Research and Design, 132: 677-685 (2018).
[35] Miller J.N., Miller J.C., “Statistics and Chemometrics for Analytical Chemistry”, Sixth ed., ISBN- 978-0-273-73042-2. (2010)