DETAILED ELECTROCHEMICAL BEHAVIOR INVESTIGATION AND DETERMINATION OF ANTIPSYCHOTIC DRUG PALIPERIDONE ON A GLASSY CARBON ELECTRODE
Yıl 2025,
Cilt: 49 Sayı: 1, 1 - 1
Sariye İrem Kaya
,
Ece Ozkan
,
Nurgul Karadas Bakirhan
,
Sibel A. Özkan
Öz
Objective: A sensitive and cost-effective electrochemical method was developed on a bare glassy carbon electrode (GCE) for the determination of paliperidone (PAL), an antipsychotic drug used in the primary schizophrenia treatment affecting the whole world.
Material and Method: The oxidation studies carried out in pH 8 phosphate buffer solution (PBS) by cyclic voltammetry (CV) showed that the oxidation reaction of PAL is a process including the same number of electrons and protons. The electrochemical detection of PAL was carried out by differential pulse voltammetry (DPV).
Result and Discussion: The linearity range was between 1 µM and 100 µM. The limit of detection (LOD) and quantification (LOQ) values were calculated as 2.41x10-7 M and 8.033x10-7 M, respectively. The applicability of the developed method was confirmed by using it on synthetic human serum. The relative standard deviation (RSD) values were less than 2%. The selectivity of the analysis was demonstrated over against interfering substances such as ascorbic acid, KNO3, MgCl2, paracetamol, dopamine, Na2SO4, and uric acid with recovery% and RSD% values in the range 98.32%-101.56% and 0.15%-1.99%, respectively. The proposed method provided high sensitivity for PAL and is the first reported method for the electroanalysis of PAL.
Etik Beyan
The authors declare that the ethics committee approval is not required for this study.
Kaynakça
- 1. Kasper, S., Papadimitriou, G.N. (2009). Schizophrenia: Vol. 2nd ed (Issue Vol. 17). Florida: CRC Press.
- 2. Korell, J., Green, B., Remmerie, B., Vermeulen, A. (2017). Determination of plasma concentration reference ranges for risperidone and paliperidone. CPT: Pharmacometrics & Systems Pharmacology, 6(9), 589-595. [CrossRef]
- 3. Chen, H., Zhao, L., Li, G., Leng, D., Ma, P., Tong, L., Zhang, T. (2014). Development and validation of a rapid and sensitive UHPLC-MS/MS method for the determination of paliperidone in beagle dog plasma. Asian Journal of Pharmaceutical Sciences, 9(5), 286-292. [CrossRef]
- 4. Patel, R.B., Patel, B.G., Patel, M.R., Bhatt, K.K. (2010). HPTLC method development and validation: Quantification of paliperidone in formulations and in vitro release study. Analytical Methods, 2(5), 525-531-531. [CrossRef]
- 5. Bindu, K.H., Dhekale, N., Suryanarayana, M.V., Anjaneyulu, Y. (2012). A validated stability indicating uplc method for simultaneous determination of assay, related substances, and degradation products of paliperidone palmitate active pharmaceutical ingredient and its pharmaceutical injection forms. Journal of Liquid Chromatography & Related Technologies, 35(4), 533-546. [CrossRef]
- 6. Dash, S.K., Acharjya, S.K., Das, P.S., Kumar, N.K., Patra, C. N. (2022). Development and validation of a first-derivative spectrophotometric method for the estimation of an antipsychotic drug in pharmaceutical formulations and forced degradation studies. Journal of Applied Spectroscopy, 88(6), 1276-1283. [CrossRef]
- 7. Citrome, L. (2012). Oral paliperidone extended-release: Chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability. Expert Opinion on Drug Metabolism & Toxicology, 8(7), 873-888. [CrossRef]
- 8. Atila Karaca, S., Yeniceli Uğur, D. (2018). Chemometrically assisted optimization and validation of a new HPLC method for the determination of paliperidone in pharmaceuticals. Journal of Liquid Chromatography and Related Technologies, 41(3), 129-134. [CrossRef]
- 9. Yamagishi, Y., Inokuchi, G., Hoshioka, Y., Nagasawa, S., Iwase, H., Ogra, Y. (2023). Identification of postmortem paliperidone metabolite in human blood by LC-Q-Orbitrap-MS. Journal of Analytical Toxicology, 47(6), 517-522. [CrossRef]
- 10. Jadhav, S.A., Landge, S.B., Choudhari, P.M., Solanki, P.V., Bembalkar, S.R., Mathad, V.T. (2011). Stress degradation behavior of paliperidone, an antipsychotic drug, and development of suitable stability-indicating RP-LCMethod. Chromatography Research International, 2011(1), 256812.
- 11. Shirode, A., Garade, C., Kadam, V. (2018). Development and validation of HPTLC method for quantitative estimation of paliperidone. Indian Drugs, 55(9), 34-40.
- 12. De Meulder, M., Remmerie, B.M.M., de Vries, R., Sips, L.L.A., Boom, S., Hooijschuur, E.W.J., van de Merbel, N.C., Timmerman, P.M.M.B.L. (2008). Validated LC-MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine. Journal of Chromatography B, 870(1), 8-16. [CrossRef]
- 13. Ruan, C.J., Zhou, M., Guo, G.X., Li, W.B., Guo, W., Wang, C.Y., de Leon, J. (2018). Quantitative determination of risperidone, paliperidone and olanzapine in human serum by liquid chromatography-tandem mass spectrometry coupled with on-line solid-phase extraction. Biomedical Chromatography, 32(7), e4209. [CrossRef]
- 14. Brett, C.M.A., Olıveira Brett, A.M. (1993). Electrochemistry: Principles, methods, and applications. Oxford University Press.
- 15. Arvand, M., Ardaki, M.S., Zanjanchi, M.A. (2015). A new sensing platform based on electrospun copper oxide/ionic liquid nanocomposite for selective determination of risperidone. RSC Advances, 5(51), 40578-40587. [CrossRef]
- 16. European Medicines Agency. (1995). Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation (ICH) Guideline, ICH Topic Q2 (R1).
- 17. Bocato, M.Z., Simões, R.A., Calixto, L.A., de Gaitani, C.M., Pupo, M.T., De Oliveira, A.R.M. (2012). Solid phase microextraction and LC-MS/MS for the determination of paliperidone after stereoselective fungal biotransformation of risperidone. Analytica Chimica Acta, 742, 80-89. [CrossRef]
- 18. Umamahesswar, K., Ramu, G., Rambabu, C. (2012). A reverse phase hplc method development and validation for the determination of paliperidone in pure and dosage forms. Chemical Science Transactions, 2(1), 41-46.
- 19. Mendez, A., Cassol, J., Camargo, V., Malesuik, M., Garcia, C. (2013). Quantitative determination of paliperidone in OROS® tablets by derivative spectrophotometric method-application in extraction and comparison to HPLC. Current Analytical Chemistry, 10(1), 158-165. [CrossRef]
- 20. Suman Panda, S., Beg, S., Ravi, K., Varaha, V., Priyadarshini, S. (2015). Quality-By-Design compliant ultrafast liquid chromatographic method for determination of paliperidone in extended release tablet dosage form. Journal of Bioanalysis & Biomedicine, 7(4), 4. [CrossRef]
CAMSI KARBON ELEKTROT İLE ANTİPSİKOTİK İLAÇ PALIPERİDONUN AYRINTILI ELEKTROKİMYASAL DAVRANIŞININ ARAŞTIRILMASI VE TAYİNİ
Yıl 2025,
Cilt: 49 Sayı: 1, 1 - 1
Sariye İrem Kaya
,
Ece Ozkan
,
Nurgul Karadas Bakirhan
,
Sibel A. Özkan
Öz
Amaç: Tüm dünyayı etkileyen şizofreninin birincil tedavisinde kullanılan antipsikotik ilaç olan paliperidonun (PAL) tayini için yalın camsı karbon elektrot (CKE) kullanılarak hassas ve uygun maliyetli bir elektrokimyasal yöntem geliştirildi.
Gereç ve Yöntem: pH 8 fosfat tampon çözeltisinde dönüşümlü voltametri (DV) ile gerçekleştirilen oksidasyon çalışmaları, PAL'ın oksidasyon reaksiyonunun iki elektron ve iki protonlu bir süreç olduğunu gösterdi. PAL'ın elektrokimyasal tespiti diferansiyel puls voltametrisi (DPV) ile gerçekleştirildi.
Sonuç ve Tartışma: Doğrusal aralık 1x10-6 M ile 1x10-4 M arasında bulundu. Teşhis sınırı (TS) ve tayin alt sınırı (TAS) değerleri sırasıyla 2.41x10-7 M ve 8.033x10-7 M olarak hesaplandı. Geliştirilen yöntemin uygulanabilirliği sentetik insan serumu üzerinde kullanılarak doğrulandı. Bağıl standart sapma (BSS) değerleri %2'den azdı. Yöntemin seçiciliği, askorbik asit, KNO3, MgCl2, parasetamol, dopamin, Na2SO4 ve ürik asit gibi girişim etkili ajanların varlığında sırasıyla %98.32-%101.56 ve %0.15-%1.99 aralığında %geri kazanım ve %BSS değerleri ile gösterilmiştir. Önerilen yöntem PAL için yüksek hassasiyet sağlamıştır ve PAL'in elektroanalizi için bildirilen ilk yöntemdir.
Kaynakça
- 1. Kasper, S., Papadimitriou, G.N. (2009). Schizophrenia: Vol. 2nd ed (Issue Vol. 17). Florida: CRC Press.
- 2. Korell, J., Green, B., Remmerie, B., Vermeulen, A. (2017). Determination of plasma concentration reference ranges for risperidone and paliperidone. CPT: Pharmacometrics & Systems Pharmacology, 6(9), 589-595. [CrossRef]
- 3. Chen, H., Zhao, L., Li, G., Leng, D., Ma, P., Tong, L., Zhang, T. (2014). Development and validation of a rapid and sensitive UHPLC-MS/MS method for the determination of paliperidone in beagle dog plasma. Asian Journal of Pharmaceutical Sciences, 9(5), 286-292. [CrossRef]
- 4. Patel, R.B., Patel, B.G., Patel, M.R., Bhatt, K.K. (2010). HPTLC method development and validation: Quantification of paliperidone in formulations and in vitro release study. Analytical Methods, 2(5), 525-531-531. [CrossRef]
- 5. Bindu, K.H., Dhekale, N., Suryanarayana, M.V., Anjaneyulu, Y. (2012). A validated stability indicating uplc method for simultaneous determination of assay, related substances, and degradation products of paliperidone palmitate active pharmaceutical ingredient and its pharmaceutical injection forms. Journal of Liquid Chromatography & Related Technologies, 35(4), 533-546. [CrossRef]
- 6. Dash, S.K., Acharjya, S.K., Das, P.S., Kumar, N.K., Patra, C. N. (2022). Development and validation of a first-derivative spectrophotometric method for the estimation of an antipsychotic drug in pharmaceutical formulations and forced degradation studies. Journal of Applied Spectroscopy, 88(6), 1276-1283. [CrossRef]
- 7. Citrome, L. (2012). Oral paliperidone extended-release: Chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability. Expert Opinion on Drug Metabolism & Toxicology, 8(7), 873-888. [CrossRef]
- 8. Atila Karaca, S., Yeniceli Uğur, D. (2018). Chemometrically assisted optimization and validation of a new HPLC method for the determination of paliperidone in pharmaceuticals. Journal of Liquid Chromatography and Related Technologies, 41(3), 129-134. [CrossRef]
- 9. Yamagishi, Y., Inokuchi, G., Hoshioka, Y., Nagasawa, S., Iwase, H., Ogra, Y. (2023). Identification of postmortem paliperidone metabolite in human blood by LC-Q-Orbitrap-MS. Journal of Analytical Toxicology, 47(6), 517-522. [CrossRef]
- 10. Jadhav, S.A., Landge, S.B., Choudhari, P.M., Solanki, P.V., Bembalkar, S.R., Mathad, V.T. (2011). Stress degradation behavior of paliperidone, an antipsychotic drug, and development of suitable stability-indicating RP-LCMethod. Chromatography Research International, 2011(1), 256812.
- 11. Shirode, A., Garade, C., Kadam, V. (2018). Development and validation of HPTLC method for quantitative estimation of paliperidone. Indian Drugs, 55(9), 34-40.
- 12. De Meulder, M., Remmerie, B.M.M., de Vries, R., Sips, L.L.A., Boom, S., Hooijschuur, E.W.J., van de Merbel, N.C., Timmerman, P.M.M.B.L. (2008). Validated LC-MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine. Journal of Chromatography B, 870(1), 8-16. [CrossRef]
- 13. Ruan, C.J., Zhou, M., Guo, G.X., Li, W.B., Guo, W., Wang, C.Y., de Leon, J. (2018). Quantitative determination of risperidone, paliperidone and olanzapine in human serum by liquid chromatography-tandem mass spectrometry coupled with on-line solid-phase extraction. Biomedical Chromatography, 32(7), e4209. [CrossRef]
- 14. Brett, C.M.A., Olıveira Brett, A.M. (1993). Electrochemistry: Principles, methods, and applications. Oxford University Press.
- 15. Arvand, M., Ardaki, M.S., Zanjanchi, M.A. (2015). A new sensing platform based on electrospun copper oxide/ionic liquid nanocomposite for selective determination of risperidone. RSC Advances, 5(51), 40578-40587. [CrossRef]
- 16. European Medicines Agency. (1995). Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation (ICH) Guideline, ICH Topic Q2 (R1).
- 17. Bocato, M.Z., Simões, R.A., Calixto, L.A., de Gaitani, C.M., Pupo, M.T., De Oliveira, A.R.M. (2012). Solid phase microextraction and LC-MS/MS for the determination of paliperidone after stereoselective fungal biotransformation of risperidone. Analytica Chimica Acta, 742, 80-89. [CrossRef]
- 18. Umamahesswar, K., Ramu, G., Rambabu, C. (2012). A reverse phase hplc method development and validation for the determination of paliperidone in pure and dosage forms. Chemical Science Transactions, 2(1), 41-46.
- 19. Mendez, A., Cassol, J., Camargo, V., Malesuik, M., Garcia, C. (2013). Quantitative determination of paliperidone in OROS® tablets by derivative spectrophotometric method-application in extraction and comparison to HPLC. Current Analytical Chemistry, 10(1), 158-165. [CrossRef]
- 20. Suman Panda, S., Beg, S., Ravi, K., Varaha, V., Priyadarshini, S. (2015). Quality-By-Design compliant ultrafast liquid chromatographic method for determination of paliperidone in extended release tablet dosage form. Journal of Bioanalysis & Biomedicine, 7(4), 4. [CrossRef]