RESEARCH PAPER
Sensitive and selective extraction-free spectrophotometric determination of quetiapine fumarate in pharmaceuticals using two sulphonthalein dyes
 
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Department of Chemistry, Manasagangothri, University of Mysore, Mysore, India
 
 
Corresponding author
Kanakapura Basavaiah   

Department of Chemistry, Manasagangothri, University of Mysore, Mysore-570 006, India.
 
 
J Pre Clin Clin Res. 2010;4(1):24-31
 
KEYWORDS
ABSTRACT
Two direct, simple, sensitive and rapid extraction-free spectrophotometric methods have been developed for the determination of quetiapine fumarate (QTF) in pure form and in its dosage forms. The methods are based on the formation of ion-pair complex between the drug and two sulphonthalein acidic dyes, namely, bromophenol blue (method A) and thymol blue (method B), followed by the measurement of absorbance at 410 and 380 nm, respectively. Conformity to Beer’s law enabled the assay of the drug in the range 1-20 and 1.5-30 μg mL-1 in method A and method B with apparent molar absorptivities of 2.97 × 104 and 1.97 × 104 L mol-1cm-1, respectively. The Sandell sensitivity values, limits of detection (LOD) and quantifi cation (LOQ) values have also been reported for both the methods. The stoichiometry of the reaction in both cases was accomplished adopting the limiting logarithmic method and was found to be 1:2 (drug:dye). The accuracy and precision of the methods were evaluated on intra-day and inter-day basis; the relative error (%RE) was ≤ 3.5% and the relative standard deviation (RSD) was < 3%. The methods were successfully applied to the determination of drug in tablets without interference by the common co-formulated substances. Statistical comparison of the results with the reference method showed good concurrence and indicated no signifi cant diff erence in accuracy and precision
 
REFERENCES (56)
1.
Arnt J, Skarsfeldt T: Do Novel Antipsychotics Have Similar Pharmacological Characteristics? A Review of the Evidence. Neuropsychopharmacology 1998, 18, 63-101.
 
2.
Balestrieri M, Vampini C, Bellantuno C: Effi cacy and safety of novel antipsychotics: a critical review. Hum Psychopharmacol 2000, 15, 499- 512.
 
3.
Chakos M, Lieberman J, Hoff man E, Bradford D, Sheitmann B: Eff ectiveness of Second-Generation Antipsychotics in Patients With Treatment-Resistant Schizophrenia: A Review and Meta-Analysis of Randomized Trials. American J Psychiatry 2001, 158, 518-526.
 
4.
Keck Jr PE, McElroy SL, Strakowski SM: Schizoaff ective disorder: role of atypical antipsychotics. Schizophrenia Res Suppl 1999, 35 S5-S12.
 
5.
AstraZeneca (13.1.2004): AstraZeneca Receives FDA Approval for SEROQUEL in Bipolar Mania, at: http://en.wikipedia.org/wiki/ Quetiapine.
 
6.
Belal F, Elbrashy A, Eid M, Nasr JJ: Stability-indicating HPLC method for the determination of quetiapine: application to tablets and human plasma. J Liquid Chromatogr Rel Technol 2008, 31, 1283-1298.
 
7.
Davis PC, Wonga AJ, Gefvertb O: Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection. J Pharma Biomed Anal 1999, 20, 271-282.
 
8.
Sachse J, Koller J, Hartter S, Hiemke C: Automated analysis of quetiapine and other antipsychotic drugs in human blood by high performanceliquid chromatography with column-switching and spectrophotometric detection. J Chromatogr B 2006, 830, 342-348.
 
9.
Saracino MA, Mercolini L, Flotta G, Albers LJ, Merli R, Raggi MA: Simultaneous determination of fl uvoxamine isomers and quetiapine in human plasma by means of high-performance liquid chromatography. J Chromatogr B Anal Tech Biomed Life Sci 2006, 843, 227-233.
 
10.
Mandrioli R, Fanali S, Ferranti A, Raggi MA: HPLC analysis of the novel antipsychotic drug quetiapine in human plasma. J Pharma Biomed Anal 2002, 30, 969-977.
 
11.
Frahnert C, Rao ML, Grasmader K: Analysis of eighteen antidepressants, four atypical antipsychotics and active metabolites in serum by liquid chromatography: a simple tool for therapeutic drug monitoring. J Chromatogr B 2003, 794, 35-47.
 
12.
Hasselstroem J, Linnet K: Fully automated on-line quantifi cation of quetiapine in human serum by solid phase extraction and liquid chromatography. J Chromatogr Anal Technol Biomed Life Sci 2003, 798, 9-16.
 
13.
Li WB, Xue YZ, Zhai YM, Zhang J, Guo GX, Wang CY, Cai ZJ: Determination of quetiapine fumarate in serum by HPLC with ultraviolet detection. Yaowu Fenxi Zazhi 2003, 23, 247-251.
 
14.
Bellomarino SA, Brown AJ, Conlan XA, Barnett NW: Preliminary evaluation of monolithic column high-performance liquid chromatography with tris(2,2′ bipyridyl)ruthenium(II) chemiluminescence detection for the determination of quetiapine in human body fl uids. Talanta 2009, 77, 1873-1876.
 
15.
Li KY, Cheng ZN, Li X, Bai XL, Zhang BK, Wang F, Li HD: Simultaneous determination of quetiapine and three metabolites in human plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry. Acta Pharmacol Sin 2004, 25, 110-114.
 
16.
Zhou Z L, Li X, Li KY, Xie ZH, Cheng ZN, Peng WX, Wang F, Zhu RH, Li HD: Simultaneous determination of clozapine, olanzapine, risperidone and quetiapine in plasma by high-performance liquid chromatographyelectrospray ionization mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2004, 802, 257-262.
 
17.
Li Z, Tan ZR, Ouyang DS, Wang G, Wang LS, Zhou G, Guo D, Chen Y, Zhou HH: HPLC - MS/MS determination of quetiapine in human plasma. Yaowu Fenxi Zazhi 2008, 28, 706-708.
 
18.
Lin SN, Chang Y, Moody DE, Foltz RL: A liquid chromatographicelectrospray- tandem mass spectrometric method for quantitation of quetiapine in human plasma and liver microsomes: application to a study of in vitro metabolism. J Anal Tox 2004, 28, 443-448.
 
19.
Barrett B, Holcapek M, Huclova J, Borek-Dohalsky V, Fejt P, Nemec B, Jelinek I: Validated HPLC-MS/MS method for determination of quetiapine in human plasma. J Pharm Biomed Anal 2007, 44, 498- 495.
 
20.
Nirogi R, Bhyrapuneni G, Kandikere V, Mudigonda K, Ajjala D, Mukkanti K: Sensitive liquid chromatography tandem mass spectrometry method for the quantifi cation of Quetiapine in plasma. Biomed Chromatogr 2008, 22, 1043–1055.
 
21.
Tan A, Pellerin B, Couture J, Vallee F: An automated SPE extraction method for the rapid analysis of quetiapine in human EDTA K2 plasma by LC/MS/MS. SFBC Anafarm, at: http://www.aapsj.org/abstracts... AM_2006/staged/AAPS2006-000989.PDF.
 
22.
Kundlik ML, Kambli S, Shah V, Patel Y, Gupta S, Sharma R, Zaware B, Kuchekar SR: Quantifi cation of Quetiapine in Human Plasma by LC–MS–MS. Chromatographia 2009, 70, 1587-1592.
 
23.
Li KY, Zhou YG, Ren HY, Wang F, Zhang BK, Li HD: Ultraperformance liquid chromatography–tandem mass spectrometry for the determination of atypical antipsychotics and some metabolites in in vitro samples. J Chromatogr B 2007, 850, 581-585.
 
24.
Tu JY, Xu P, Xu DH, Li HD: UPLC-MS-MS analysis of quetiapine and its two active metabolites, 7-hydroxyquetiapine and 7-hydroxy- N-dealkylquetiapine, in rat plasma and cerebrospinal fluid. Chromatographia 2008, 68, 525-532.
 
25.
McMullin MM: Development of a gas chromatographic method for the mdetermination of quetiapine in human serum, and a report of patient values. Ther Drug Monit 1999, 21, 459-459.
 
26.
Atanasov VN, Kanev KP, Mitewa MI: Detection and identifi cation of atypical quetiapine metabolite in urine. Central Europ J Med 2008, 3, 327-331.
 
27.
Ozkan SA, Dogan B, Uslu B: Voltammetric analysis of the novel atypical antipsychotic drug quetiapine in human serum and urine. Microchim Acta 2006, 153, 27-35.
 
28.
El-Enany N, El-Brashy A, Belal F, El-Bahay N: Polarographic analysis of quetiapine in pharmaceuticals. Portugaliae Electrochimica Acta 2009,27, 113-125.
 
29.
Pucci V, Mandrioli R, Ferranti A, Furlanetto S, Raggi MA: Quality control of commercial tablets containing the novel antipsychotic quetiapine. J Pharm Biomed Anal 2003, 32, 1037-1044.
 
30.
Hillaert S, Snoeck L, van den Bossche W: Optimization and validation of a capillary zone electrophoretic method for the simultaneous analysis of four atypical antipsychotics. J Chromatogr 2004, 1033, 357-362.
 
31.
Dhandapani B, Somasundaram A, Raseed SH, Raja M, Dhanabal K: Development and validation of HPTLC method for estimation of quetiapine in bulk drug and in tablet dosage form. Int J PharmTech Res 2009, 1, 139-141.
 
32.
Skibiński R, Komsta Ł, Kosztyła I: Comparative validation of quetiapine Determination in tablets by NP-HPTLC and RP-HPTLC with densitometric and videodensitometric detection. J Planar Chromatogr Modern TLC 2008, 21, 289-294.
 
33.
Dhaneshwar SR, Patre NG, Mahadik MV: Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form. Acta Chromatographia 2009, 21, 83-93.
 
34.
Radha Krishna S, Rao BM, Someswara Rao N: A validated stability indicating hplc method for the determination of related substances in quetiapine fumarate. Rasayan J Chem 2008, 1, 466-474.
 
35.
Bharathi CH, Prabahar KJ, Prasad CHS, Srinivasa Rao M, Trinadhachary GN, Handa VK, Dandala R, Naidu A: Identifi cation, isolation, synthesis and characterization of impurities of quetiapine fumarate. Pharmazie 2008, 63, 14-19.
 
36.
Fu CM, Wang RZ: Reversed phase-HPLC determination of quetiapine fumarate in tablets. Zhongguo Xinyao Zazhi 2002, 11, 144-146.
 
37.
Raju IVS, Raghuram P, Sriramulu J: Development and Validation of a New Analytical Method for the Determination of Related Components in Quetiapine Hemifumarate. Chromatographia 2009, 70, 545.
 
38.
Fursule RA, Rupala DK, Mujeeb Gulzar Khan Md, Shirkhedkar AA, Surana SJ: Determination of quetiapine fumarate and cilostazol in bulk and tablet by uv spectrophotometry. Biosci Biotechnol Res Asia 2008 (May), at: http://www.biotech-asia.org/di....
 
39.
Arulappa RX, Sundarapandian M, Venkataraman S, Boopathi M, Kaurav M: Spectrophotometric Determination of Quetiapine Fumarate in Bulk and Dosage Form. Res J Pharm Tech 2009, 2, 884.
 
40.
Onal A, Kepekci SE, Oztunc A: Spectrophotometric methods for the determination of the antidepressant drug paroxetine hydrochloride in tablets. J AOAC Intl 2005, 88, 490-495.
 
41.
Rahman N, Ahmad Khan N, Hejaz ASN: Extractive spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations using bromocresol green, bromophenol blue, bromothymol blue and eriochrome black T. IL Farmaco 2004, 59, 47-54.
 
42.
Ramesh KC, Gowda BG, Melwanki MB, Seetharamappa J, Keshavayya J: Extractive spectrophotometric determination of antiallergic drugs in pharmaceutical formulations using bromopyrogallol red and bromothymol blue. Anal Sci 2001, 17, 1101-1103.
 
43.
Rahman N, Hejaz-Azmi SN: Extractive spectrophotometric methods for determination of diltiazem HCl in pharmaceutical formulations using bromothymol blue, bromophenol blue and bromocresol green. Pharm J Biomed Anal 2000, 24, 33-41.
 
44.
Silva N, Schapoval EES: Spectrophotometric determination of etidocaine in pharmaceutical (dental) formulation. J Pharm Biomed Anal 2002, 29, 749-754.
 
45.
Perez-Ruiz T, Martinez-Lozano C, Tomas V, Sanz A, Sahuguillo E: Flowinjection extraction-spectrophotometric method for the determination of ranitidine in pharmaceutical preparations. J Pharm Biomed Anal 2001, 26, 609-615.
 
46.
Basavaiah K, Charan VS: Titrimetric and spectrophotometric assay of some antihistamines through the determination of the chloride of their hydrochlorides. IL Farmaco 2002, 57, 9-17.
 
47.
Maghsoudi H, Fawzi A: Direct spectrophotometric determination of thebaine in Arya II population capsules of Papaver bracteatum Lindi. J Pharm Sci 1978, 67, 32-35.. Farsam H, Yahya-saeb HH, Fawzy A: Spectrophotometric determination of codeine in pharmaceutical preprations. Int J Pharm 1981, 7, 343- 348.
 
48.
El-Kerdawy MM, Moustafa MA, El-Ashry SM, El-Waseef DR: Spectrophotometric determination of certain phenothiazines and their dosage forms using Bromophenol blue. Anal Lett 1993, 26, 1669- 1680.
 
49.
Abdine HH: Spectrophotometric determination of cisapride using some sulfonphthalein dyes. Alex J Pharm Sci 2000, 14, 75-78.
 
50.
Abdine H, Belal F, Zoman N: Simple spectrophotometric determination of cinnarizine in its dosage forms. Il Farmaco 2002, 57, 267-271.
 
51.
Manjunatha DH, Shaikh SMT, Harikrishna K, Sudhirkumar R, Kandagal PB Seetharamappa: Simple and sensitive spectrophotometric methods for the determination of acebutolol hydrochloride in bulk sample and pharmaceutical preparations. Ecl Quim Sao Paulo 2008, 33, 37-40.
 
52.
Safwan Ashour, Fawaz Chehna M, Roula Bayram: Spectrophotometric Determination of Alfuzosin HCl in Pharmaceutical Formulations with some Sulphonephthalein Dyes. Intl J Biomed Sci 2006, 2, 273-278.
 
53.
Rose J: Advanced Physico-chemical Experiments, Pitman and Sons, London 1964, 67.
 
54.
Zavis H, Ludvik D, Milan K, Ladislaw S, Frantisck V: Handbook of Organic Reagents in Inorganic Analysis. (Transl. & Ed.: Chalmers, SK), Ellis Horwood Ltd., Chichester (UK), a Division of John Wiley & Sons Inc., New York, London, Sydney, Toronto 1976, p.364.
 
55.
International Conference on Hormonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology, 6 November 1996, incorporated in November 2005, London.
 
56.
Inczedy J, Lengyel T, Ure AM, IUPAC Compendium of Analytical Nomenclature : Defi nitive Rules, Blackwell Science Inc., Boston 1998.
 
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