Farmasötik Formülasyonlarda ve Saf Formda Ketiapin Miktar Tayini İçin Operatör ve Çevre Dostu Analitik Tekniklerin Geliştirilmesi ve Validasyonu

Year 2025, Volume: 25 Issue: 1, 70 - 80

İbrahim Demir , İbrahim Bulduk , Hüseyin Enginar , Cemal Çifci

Abstract

Ketiapin, şizofreni, majör depresif bozukluk ve bipolar bozukluk tedavisinde kullanılan bir tür atipik antipsikotik ajandır. Bu çalışmada, ketiapinin saf ve formülasyonlarda miktar tayini için çevresel ve operatör dostu analitik yöntemler geliştirilmiştir. En iyi spektrumlar ultra saf su ile elde edildiği için, bu çözücü spektrofotometrik analiz için kullanıldı. Ketiapin standart çözeltilerinin 290 nm dalga boyunda UV ışığını maksimum düzeyde absorbe ettiği tespit edilmiş ve tespit için 290 nm dalga boyu seçilmiştir. Her iki yöntem de ICH kurallarına göre doğrulandı. Geliştirilen yöntemlerle 5-30 µg mL-1 konsantrasyon aralığında korelasyon katsayılarının 0,999'dan büyük olduğu tespit edildi. Geliştirilen yöntemler ticari formülasyonlara uygulanmıştır. Elde edilen sonuçlar ortalamalar için Student (t) testi ve standart sapmalar için Fischer (F) testi kullanılarak karşılaştırılmıştır. Yöntemler arasında önemli bir fark gözlenmemiştir. Geliştirilen yöntemlerin yeşillik değerlendirmesi AGREE yazılımı kullanılarak gerçekleştirilmiştir. Geliştirilen analitik yöntemler, ticari formülasyonlarda ketiapin miktar tayini için mükemmel çevresel ve analist dostu alternatifler olarak önerilmektedir.

Keywords

Ketiapin, farmasötikler, yeşil analitik yöntem, validasyon.

Ethical Statement

etik beyana ihtiyaç yoktur.

Supporting Institution

yok

Project Number

proje numarası yok

Thanks

yok

Development and Validation of Operator and Environmentally Friendly Analytical Techniques for Quetiapine Quantification in Pharmaceutical Formulations and Pure Form

Abstract

Quetiapine is a kind of atypical antipsychotic agent used in the treatment of schizophrenia, major depressive disorder and bipolar disorder. In this study, environmental and operator-friendly analytical methods were developed for the quantification of quetiapine in pure and formulations. Since the best spectra were obtained with ultrapure water, this solvent was used for spectrophotometric analysis. Quetiapine standard solutions were found to maximally absorb UV light at a wavelength of 290 nm and a wavelength of 290 nm was chosen for detection. Both methods were validated according to ICH guidelines. The correlation coefficients were found to be greater than 0.999 in the concentration range of 5-30 µg mL-1 with the developed methods. The developed methods were applied to commercial formulations. The results were compared using Student (t) test for means and Fischer (F) test for standard deviations. No significant difference was observed between the methods. The greenness evaluation of the developed methods was carried out using AGREE software. The developed analytical methods are recommended as excellent environmental and analyst-friendly alternatives for the quantification of quetiapine in commercial formulations.

Keywords

Quetiapine, pharmaceuticals, green analytical method

Project Number

proje numarası yok

References

• Armenta, S., Garrigues, S., Guardia, de la M. (2008). Greening analytical chemistry, TrAC: Trends Anal. Chem. 27, 497–511. http://dx.doi.org/10.1016/j.trac.2008.05.003
• Arulappa R.X., Sundarapandian M., Singh R., Venkataraman S. (2009). Spectrophotometric Method for Estimation of Quetiapine Fumarate in Bulk and Dosage Form, Asian Journal of Research in Chemistry, 2, 452-453.
• Assassi AL, Roy CE, Perovitch P, Auzerie J, Hamon T, Gaudin K. (2015). Green analytical method development for statin analysis. J Chromatogr A. Feb 6;1380:104-11. http://doi.org/10.1016/j.chroma.2014.12.066
• Aybaba, C., Caglayan, M., Palabiyik, I., Onur, F. (2012). Spectrophotometric methods for determination of quetiapine hemifumarate in pharmaceutical preparations using bromcresol purple and bromcresol green, Turkish Journal Of Pharmaceutical Sciences, 9, 301-310.
• Basavaiah, K., Rajendraprasad, N., Ramesh, P., Vinay, K. (2010). Sensitive ultraviolet spectrophotometric determination of quetiapine fumarate in pharmaceuticals, Thai Journal of Pharmaceutical Sciences, 34, 146-154. http://doi.org/10.56808/3027-7922.2177
• Belal, F., Elbrashy, A., Eid, M., Nasr, J.J. (2008). Stability‐Indicating HPLC method for the determination of quetiapine: application to tablets and human plasma, J. Liq. Chromatogr. Relat. Technol. 31 (9), 1283–1298. https://doi.org/10.1080/10826070802019681
• Bellomarino, S.A., Brown, A.J., Conlan, X.A., Barnett, N.W. (2009). 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 fluids, Talanta 77 (5), 1873–1876. http://doi.org/10.1016/j.talanta.2008.10.023
• Burns, M.J. (2001). The pharmacology and toxicology of atypical antipsychotic agents, J. Toxicol. Clin. Toxicol. 39 (1), 1–14. http://doi.org/10.1081/CLT-100102873
• Center for Drug Evaluation and Research (CDER). Reviewer Guidance: Validation of Chromatographic Methods; 1994.
• Dalvi, S.D., Nanda, R.K., Chitlange, S.S. (2018). Design of experiment in the bio-analytical determination of quetiapine fumarate in human plasma by a rp-hplc method, Int. J. Pharm. Sci. Res. 9 (7), 2875–2882.
• Dedania, Z.R., Sheth, N.R., Dedania, R.R. (2013). Stability indicating high-performance thin-layer chromatographic determination of quetiapine fumarate, Int. J. Pharm. Sci. Res. 4 (6), 2406–2414. http://dx.doi.org/10.13040/IJPSR.0975-8232.4(6).2406-14
• Dogan, A., Can, C., Nursabah E., Akduman, B. (2020). Application of green methodology to pharmaceutical analysis using eco-friendly ethanol-water mobile phases, Microchemical Journal, Volume 157, 104895. https://doi.org10.1016/j.trac.2008.05.003.
• Hussain, S., Mustafa, S.y.g.f., Salim, S. (2018). Oxidation of quetiapine by potassium dichromate in acid medium: A kinetic study, International Journal of Pharmaceutical Research, 10, 172-177. https://doi.org/10.31838/ijpr/2018.10.03.068
• Ingale, P.L. , Dalvi, S.D., Gudi, S.V., Patil, L.D., Jadav, D.D., Kadam, Y.A. (2013). Development of analytical method for determination of quetiapine fumarate in bulk and tablet dosage form, Der. Pharma. Chemica, 5, 26–30.
• Karaca, S.A., Yilmaz, I.T., Şener, E., Uğur, D. (2016). Development and validation of a new HPLC method for the determination of quetiapine and its metabolites 7-hydroxy quetiapine and quetiapine sulfoxide in rat plasma, Turk. J. Pharm. Sci. 13 (1), 17–27. http://doi.org/10.5505/tjps.2016.46855 Khanvilkar, V.V., Parmar, D., Dalvi, V.J., Tambe, A., Kadam, V.J. (2013). High performance thin layer chromatographic method for estimation of quetiapine fumarate from human plasma, Indo Am. J. Pharm. Res. 3, 7532–7540.
• Koel, M., Kaljurand, M. (2006). Application of the principles of green chemistry in analytical chemistry, Pure Appl. Chem. 78 1993–2002. https://doi.org10.1351/pac200678111993.
• Krishna, S.R., Rao, B.M., & Rao, N.S. (2008). A validated stability indicating hplc method for the determination of related substances in quetiapine fumarate. Rasayan J. Chem. 1(3), 466–474.
• Kumar, N., Sangeetha, D., Goyal, R., Reddy, P.S. (2013). A validated stability-indicating RPLC method for the estimation of process-related impurities and degradation products of quetiapine fumarate in solid oral dosage form, Acta Chromatogr. 25 (2), 393–409 http://doi.org/10.1556/AChrom.25.2013.2.13
• Kunte, S., Wagh, R. (2009). Estimation of quetiapine in bulk drug and tablet dosage form, International journal of chemical science, 7, 951-960.
• Lakshmi, P.B.S., Rambabu, C. (2012). Use of ion association reactions for the spectrophotometric determination of quetiapine, Asian Journal of Chemistry, 24, 3521-3523.
• Nagaraju, P. (2015). Development and validation of RP-HPLC method for estimation of quetiapine fumarate in pharmaceutical formulations, Pharm. Method. 6(2), 105–108 http://doi.org/10.5530/phm.2015.6.15
• Pena-Pereira, F., Wojnowski, W., & Tobiszewski, M. (2020). AGREE—Analytical GREEnness metric approach and software. Anal. Chem., 92, 10076–10082. http://doi.org/10.1021/acs.analchem.0c01887
• Płotka, J., Tobiszewski, M., Sulej, A.M., Kupska, M. Gorecki, T., Namiesnik, J. (2013). Green chromatography, J. Chromatogr. A 1307, 1–20. http://doi.org/10.1016/j.chroma.2013.07.099
• Płotka-Wasylka, J. A. (2018). A new tool for the evaluation of the analytical procedure: Green analytical procedure index, Talanta, 181, 204–209. https://doi.org/10.1016/j.talanta.2018.01.013
• Pucci V., Mandrioli R., Ferranti A., Furlanetto S., Raggi M.A. (2003). Quality control of commercial tablets containing the novel antipsychotic quetiapine, Journal of pharmaceutical and biomedical analysis, 32 1037-1044. https://doi.org/10.1016/S0731-7085(03)00206-1
• Rajendraprasad, N., Basavaiah, K. (2017). U.R.A. Kumar, Isocratic ultra-performance liquid chromatographic assay of quetiapine fumarate in pharmaceuticals, Thai J. Pharm. Sci. 41 (1), 6–11.
• Rajendraprasad, N., Basavaiah, K., Vinay, B.K. (2011) Extractive spectrophotometric determination of quetiapine fumarate in pharmaceuticals and human urine using calmagite as an ion-pair reagent, Chemical Industry and Chemical Engineering Quarterly/CICEQ, 17, 259- 267. http://doi.org/10.2298/CICEQ101124010R
• Rajendraprasad, N., Basavaiah, K., Vinay, K.B. (2010). Sensitive and selective extraction-free spectrophotometric determination of quetiapine fumarate in pharmaceuticals using two sulphonthalein dyes, Journal of Pre-Clinical and Clinical Research, 4, 24-31.
• Rajendraprasad, N., Basavaiah, K., Vinay, K.B. (2012). Extractive spectrophotometric determination of quetiapine fumarate in pharmaceuticals and spiked human urine, Croatica Chemica Acta, 85, 9-17. https://doi.org/10.5562/cca1770
• Raju, I.S. Raghuram, P., Sriramulu, J. (2009). Development and validation of a new analytical method for the determination of related components in quetiapine hemifumarate, Chromatographia 70(3–4), 545–550. http://doi.org/10.1365/s10337-009-1183-z
• Ramadan, N.K., Mohamed, A.O., Fouad, R.M., Moustafa, A.A. (2012). Different stability-indicating methods for the determination of quetiapine fumarate. analytical chemistry, Ind. J. 12 (7), 264–276.
• Reddy, K.D., Kumar, B.V., Sayanna, K. (2014). Venkateshwalu G., Spectrophotometric determination of drugs based on oxidation by acidic KMnO4, World Journal of Pharmacy and pharmaceutical sciences, 3, 812-824. http://doi.org/10.9790/5736-0660814
• Rosa, P.C.P., Pires, I.F.R., Markman, B.E.O., Perazzo, F.F. (2013). Development and validation of RP-HPLC method for the determination of related compounds in quetiapine hemifumarate raw material and tablets, J. Appl. Pharm. Sci. 3 (8), 6–15.
• Sandra, P., Vanhoenacker, G., David, F., Sandra, K., Pereira, A. (2010). Green chromatography (part 1): introduction and liquid chromatography, LCGC Eur. 23, 242–259.
• Saracino, M.A., Mercolini, L., Flotta, G., Albers, L.J., Merli, R., Raggi, M.A. (2006). Simultaneous determination of fluvoxamine isomers and quetiapine in human plasma by means of high-performance liquid chromatography, J. Chromatogr. B 843 (2), 227–233. https://doi.org/10.1016/j.jchromb.2006.06.001
• Sathiya, R., Krishnaraj, K., Muralidharan, S., Muruganantham, N. (2014). A simple and validated HPTLC method of evaluation for quetiapine fumarate in oral solid dosage form, Eurasian J. Anal. Chem. 5 (3), 246–253.
• Sharma, D., Srinivas, K.S., Gupta, P., Dwivedi, D.P., Dureja, H., Nagpal, M., Goyal, S. (2010). Simultaneous estimation of risperidone, olanzapine, quetiapine and their degradation products by HPLC, Acta Pharm. Sci. 52 (3), 345–352.
• Shashikant, B., Narkhede, S.P., Nikam, D., Sachde, C. (2009). Development and validation of UVSpectrophotometric method for determination of Quetiapine fumarate in two different dose tablets, International Journal of ChemTech Research, 1, 898-904.
• Shen, G., Guo, L., Liu, L., Zhang, W., Liu, X. (2014). Simultaneous determination of clozapine, quetiapine and risperidone in human serum with on line solid-phase extraction-high performance liquid chromatography, Chin. J. Anal. Chem. (12), 1823–1827.
• Silva Gracia, M., Köppl, A., Unholzer, S., Haen, E. (2017). Development and validation of an HPLC‐UV method for the simultaneous determination of the antipsychotics clozapine, olanzapine, and quetiapine, several beta‐blockers and their metabolites, Biomed. Chromatogr. 31 (10) 1–11. http://doi.org/10.1002/bmc.3968
• Srihari, G., Chakravarthi, I. (2011). Simple spectrophotometric method for determination of Quetiapine fumarate in tablets, International Journal of chemical science, 9, 949-952.
• Suneetha, D., Lakshmana Rao, A. (2010). A validated rp-HPLC method for the estimation of quetiapine in bulk and pharmaceutical formulations, J. Chem. 7 (1), 61–66. http://doi.org/10.1155/2010/105963
• Talele, S.G. (2018). Stability-indicating high-performance liquid chromatography (HPLC) method development and validation for the determination of quetiapine fumarate in bulk and dosage form by HPLC, Int. J. Green Pharm. 12 (01), 188–193.
• Talusani, P., Sivasubramanian, L. (2013). Stability indicating RP-HPLC method for the estimation of quetiapine fumarate in bulk and tablet dosage form, Int. J. Pharm. Pharm. Sci. 5 (4), 269–272. http://doi.org/10.22377/ijgp.v12i01.1618
• Tobiszewski, M., Mechlinska, A. Namiesnik, J. (2010). Green analytical chemistry – theory and practice, Chem. Soc. Rev. 39 2869–2878. https://doi.org10.1039/B926439F
• Trivedi, R.K., Patel, M.C. (2011). Development and validation of a stability indicating RPUPLC method for determination of quetiapine in pharmaceutical dosage form, Sci. Pharm. 79 (1), 97–112. http://doi.org/10.3797/scipharm.1009-1
• Valarmathi R., Dhharshini, C.D., Senthamarai, R., Banu, S.F. (2013). Analytical method development of Quetiapine Fumerate in bulk and its Tablet Formulation by simple UV Spectrophotometry, International Journal of Drug Development and Research, 5, 366-372. http://doi.org/10.21608/ejchem.2020.37638.2774
• Validation of analytical procedures: text and methodology Q2(R1)-ICH harmonized tripartite guideline. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2005.
• Vinay, K., Revenasiddappa, H. (2012). Spectrophotometric determination of quetiapine fumarate in pharmaceuticals and human urine by two charge-transfer complexation reactions, Chemical Industry and Chemical Engineering Quarterly/CICEQ, 18, 263-272. http://doi.org/10.2298/CICEQ111006003V
• Welch, C.J., Wu, N., Biba, M., Hartman, R., Brkovic, T., Gong, X., Helmy, R., Schafer, W., Cuff, J. Pirzada, Z., Zhou, L. (2010). Greening analytical chromatography, TrAC: Trends Anal. Chem. 29, 667–680. http://doi.org/10.1016/j.trac.2010.03.008
• Yang, Y., Strickland, Z., Kapalavavi, B. Marple, R., Gamsky, C. (2011). Industrial application of green chromatography—I. Separation and analysis of niacinamide in skincare creams using pure water as the mobile phase, Talanta 84, 169–174. http://doi.org/10.1016/j.talanta.2010.12.044
• Youssef, R.M., Abdine, H.H., Barary, M.A., Wagih, M.M. (2016). Selective RP-HPLC method for determination of quetiapine in presence of coadministered drugs: application for long-term stability study of quetiapine in whole blood, Acta Chromatogr. 28 (3), 263–279. http://doi.org/10.1556/1326.2016.28.2.2
• https://go.drugbank.com/salts/DBSALT002790