Impact Factor: 5.6     h-index: 27

Document Type : Review Article

Authors

1 Department of Chemistry, University of Zanjan, P.O. Box: 45195-313, Zanjan, Iran.

2 Chemistry and Chemical Engineering Research Center of Iran, P.O. Box 14335-186, Tehran 1496813151, Iran

Abstract

Background: Quetiapine fumarate is a dibenzothiazepine derivative and it is classified as a second-generation antipsychotic drug that has been established as an effective therapy for schizophrenia and bipolar disorder. These antipsychotics have a low incidence of extrapyramidal side effects and tardive dyskinesi as compared to older antipsychotics. The advantages of the therapeutic profile of quetiapine have led to increasing the use of the clinical practice encouraging the development of new pharmaceutical preparations. Objective: The goal of this work was to recognize the synthesis and analytical deference methods of quetiapine fumarate. Methods: Generally, A precise, specific, rapid and feasible reversed-phase high-performance liquid chromatographic (RP-HPLC), UV spectrophotometric and reversed phase ultra-performance liquid chromatography (RP-UPLC) methods for the determination of an antipsychotic drug quetiapine fumarate in pharmaceuticals, spiked human urine and plasma sample have been developed and collected in this review. The methods also find applications in clinical, biological and pharmacokinetic studies of quetiapine fumarate.

Graphical Abstract

Quetiapine Fumarate Syntheses and Its Determination Methods in the Pharmaceutical Dosage Forms, Human Plasma and Urine by RP-HPLC and Other Analytical Techniques: A Review

Keywords

Main Subjects

[1]. Vessalli E., Edjlali L., Rezaei M., Hokmabadi F. Asian Journal of Chemistry, 2013, 25:4141
[2]. Sudarshan Reddy P., Satyanarayana P., Karthik Varma K., Naga Raju S.K.G., Shanmugasundaram P. Int. J. Pharm & Ind. Res, 2011, 1:95
[3]. Lakshmi P.B.S., Ramachandran D., Rambabu C., Asian Journal of Chemistry, 2009, 21:811
[4]. SB B., Narkhede S., Nikam D., Sachde C. 2009.
[5]. Barrett B.,  Holčapek M., Huclova J., Bořek-Dohalský V., Fejt P., Němec B., Jelinek I., Journal of pharmaceutical and biomedical analysis, 2007, 44:498
[6]. Belal F., Elbrashy A., Eid M., Nasr J.J. Journal of Liquid Chromatography & Related Technologies, 2008, 31:1283
[7]. Bellomarino S.A., Brown A.J., Conlan X.A., Barnett N.W. Talanta, 2009, 77:1873
[8]. Davis P.C., Bravo O., Gehrke M., Azumaya C.T., Journal of pharmaceutical and biomedical analysis, 2010, 51:1113
[9]. Hasselstroem J., Linnet K. Journal of Chromatography B, 2003, 798:9
[10].Kirchherr H., Kühn-Velten W. Journal of Chromatography B, 2006, 843:100
[11].Li K.Y., Cheng Z.Y., Li X., Bai X.l., Zhang B.K., Wang F., Li H.D. Acta Pharmacologica Sinica, 2004, 25:110
[12]. Li K.Y., Zhou Y.G., Ren H.Y., Wang F., Zhang B.K. Journal of Chromatography B, 2007, 850:581
[13]. Mandrioli R., Fanali S., Ferranti A., Raggi M. Journal of pharmaceutical and biomedical analysis, 2002, 30:969
[14]. Mercolini L., Grillo M., Bartoletti C., Boncompagni G., Raggi M.A. Analytical and bioanalytical chemistry, 2007, 388:235
[15]. Raju I.S., Raghuram P., Sriramulu J. Chromatographia, 2009, 70:545
[16]. Sachse J., Köller J., Härtter S., Hiemke C. Journal of Chromatography B, 2006, 830:342
[17]. Saracino M.A., Mercolini L., Flotta G., Albers L.J., Merli R., Raggi M.A., Journal of Chromatography B, 2006, 843:227
[18]. Vijaya Kumar M., Muley P. INDIAN DRUGS-BOMBAY-, 2004, 41:272
[19]. Zhou Z., Li X., Li K., Xie Z., Cheng Z., Peng W., Wang F., Zhu R., Li H. Journal of Chromatography B, 2004, 802:257
[20]. Dhandapani B., Somasundaram A., Raseed S.H., Raja M., Dhanabal K. Int. J. PharmTech Res, 2009, 1:139
[21]. Skibiński R., Komsta Ł., Kosztyła I. JPC-Journal of Planar Chromatography-Modern TLC, 2008, 21:289
[22]. Stolarczyk E.U., Groman A., Kaczmarek U.S., Golebiewski P. Acta Poloniae Pharm.-Drug Research, 2007, 64:187
[23].Hillaert S., Snoeck L., Van den Bossche W. Journal of Chromatography A, 2004, 1033:357
[24]. Pucci V., Mandrioli R., Ferranti A., Furlanetto S., Raggi M.A. Journal of pharmaceutical and biomedical analysis, 2003, 32:1037
[25]. El-Enany N., El-Brashy A., Belal F., El-Bahay N. Portugaliae Electrochimica Acta, 2009, 27:113
[26].  ICH, “Validation of Analytical Procedure, Text and Methodology” Q2(R1), International
conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.
[27]. Pawar S.S. Int J Pharm Bio Sci, 2013, 4:68
[28]. Warawa E.J., Migler B.M. Novel dibenzothiazepine antipsychotic, p. USA Patent, 1989, NO. 4879288.
[29]. Diller D., Dolitzky B.Z. Synthesis of quetiapine and pharmaceutically acceptable salts thereof , p. USA Patent, 2006, NO. 7071331.
[30]. Serafini S., Tomasi F., Galvangni M. Process for the synthesis of quetiapine, p. USA Patent, 2013, NO. 8389716.
[31]. Horrom B.W., Minard F.N., Zaugg H.E. Dibenzo[b,e][1,4]diazepines, p. USA Patent, 1978, NO. 4097597.
[32]. Czibula L., Werkne P. Synthesis for the preparation of quetiapine , PCT. Int. Appl. WO, 2008, NO. 152434.
[33]. Kwak B., Chung K., Koh K., Hwang H. Method of preparing 10Hdibenzo[b,f]]1,4]thiazepin-11-one , PCT. Int. Appl. WO, 2004, NO.047722.
[34]. Kandula V.R. Hetero letters.,2014, 4:331
[35]. Kansal V.K., Lal K., Ahmad S., Leonov D. Process for preparing quetiapine fumarate, p. USA Patent, 2010, NO. 7687622.
[36]. Grumann A., Huhta S., Rummakko P., Lusis V. Quetiapine hemifumarate purification by crystallization, p. USA Patent, 2011, NO. 8044039.
[37]. Chandra R., Sanghi A., Kumar D., Kumar Bharti Bhart A. Journal of Chemical and Pharmaceutical Research, 2016, 8:142
[38]. Nagaraju   P. Pharm Methods, 2015, 6:105
[39]. Sawsan M., Hesham S., Marianne N., El-Maraghy M. Journal of Chromatography & Separation Techniques, 2015, 6:1
[40]. Dedania Z.R., Dedania R.R., Sheth N.R.World Journal of Pharmaceutical Research 2015, 4:1474
[41]. Debnath M., Rao J., Kumar S.A. Journal of Drug Delivery and Therapeutics, 2013, 3:62
[42]. Gouthami M., Karthikeyan R., Babu P.S. Int. Res. J. Pharm.,2013, 4:89
[43]. Sivasubramanian L. Int. J. Pharm. Pharm. Sci.,2013, 5:269
[44]. Ingale P.L., Dalvi S.D., Gudi S.V., Patil L.D., Jadav D.D., Kadam Y.A. Der Pharma Chemica, 2013, 5:26
[45]. Nesrin A.O.M., Ramadan K., Fouad R.M., Moustafa A.A. Anal. Chem. An. Ind. J.,2013, 12:264
[46]. El-Shal M.A. Advanced pharmaceutical bulletin, 2013, 3:339
[47]. Rosa P.C.P., Pires I.F.R., Markman B.E.O., Perazzo F.F., Journal of Applied Pharmaceutical Science, 2013, 3:006
[48]. Valarmathi R., Dhharshini C.D., Senthamarai R., Banu S.F. Int. J. Drug Dev. & Res, 2013, 5:366
[49]. Venkata K.B., Battula S.R., Dubey S. Journal of Chemistry, 2013, 8 pages.
[50]. Aybaba C., Caglayan M.G., Palabiyik L., Onur F., Turkish Journal of Pharmaceutical Sciences, 2012, 9:301
[51]. Pant M., Khatri N. International Journal of Pharmacy & Life Sciences, 2012, 3:1802
[52]. Basavaiah K.V., Revanasiddappa O.H., Ramesh J.T.P., Rajendraprasad N. Chemical Industry and Chemical Engineering Quarterly/CICEQ, 2011, 17:99
[53]. Raju G., Ganapathy S., Sankar D., Naidu P.  Asian Journal of Research in Chemistry, 2010, 3:447
[54]. Prasanth   V., Eapan S., Kutti S., Jyothi T. Der Pharmacia Sinica, 2011, 2:52
[55]. Sravan kumar C.V.G., Vijay Kumar B., sulthana Sh., Sravan kumar S.A.V., De S. International Journal of Biological & Pharmaceutical Research, 2011, 2:27
[56]. Trivedi H.K., Patel M.C. Scientia pharmaceutica, 2012, 80:393
[57]. Rajendraprasad N., Basavaiah K., Vinay K.B. Journal of Pre-Clinical and Clinical Research, 2010, 4:24
[58]. Vinay K.B. Portugaliae Electrochimica Acta, 2010, 28:299
[59]. Basavaiah K., Rajendraprasad N., Ramesh P., Vinay K. Thai Journal of Pharmaceutical Sciences, 2010, 34:146
[60]. Bagade S.B., Narkhede S., Nikam D., Sachde C. Int.J. Chem. Tech. Res, 2009, 1:898
[61]. Krishna S.R., Rao B., Rao N.S. Rasayan jchem, 2008, 1:466
[62]. khanvilkar Vineeta C.A.P., Shirode Abhay V., Kadam Vilasrao J. Int. Res. J. Pharm.,2013, 4:92
[63]. Kanakapura B Vinaya H.D.R., Rajendraprasadb N., Pavagada J., Basavaiaha R.K. Journal of reports in pharmaceutical science, 2013, 2:131
[64]. Khanvilkar V., Parmar D., Dalvi V., Tambe A., Kadam V. Indo American Journal of Pharmaceutical Research, 2013, 3:7532
[65]. Pan R.N., Kuo B.P.C., Pao L.H. Journal of chromatographic science, 2012, 50:277
[66]. Rajendraprasad N., Basavaiah K., Vinay K.B. Croatica Chemica Acta, 2012, 85:9
[67]. Estevez-Carrizo    F.E., Parrillo S., Ercoli M.C., Estevez-Parrillo F.T. Clinical therapeutics, 2011, 33:738
[68]. Mahatthanatrakul W., Pradabsang C., Sriwiriyajan S., Ridtitid W., Wongnawa M. Basic & Clinical Pharmacology & Toxicology, 2011, 109:117
[69]. Barrett M.H.B., Huclova J., Borek-Dohalsky V., Fejt P., Nemec I.J.B. Journal of Pharmaceutical and Biomedical Analysis, 2007, 44:498