Paroksetin HCl'nin UV-VIS ile Tayin Edilmesi için Farklı Bir Analitik Yöntem

Year 2021, Volume: 3 Issue: 2, 120 - 132, 11.10.2021

Figen Erek

Abstract

Paroxetine HCl (PRX) 'in tabletten belirlenmesi için duyarlı, kolay ve seçici bir spektrofotometrik yöntem geliştirilmiştir. Bu yöntem, ilaç etken maddesinin yapısındaki ikincil amin grubu üzerinden renkli bir Cu-ditiokarbamat kompleksi oluşturulmasına dayanmaktadır. Paroxetin HCl ile oluşturulan kompleks, UV-VIS spektrofotometresi ile metilizobutilketon çözücüsü içinde 435 nm'de maksimum absorbans vermektedir. Geliştirilen yöntemde, çözücü cinsi (ekstraksiyon çözücüsü), NH3 konsantrasyonu, CS2 konsantrasyonu, Cu2 + konsantyasyonu ve reaksiyon süresinin etkisi araştırılmıştır. Daha sonra yöntem istatistiksel olarak doğrulanmıştır. Yöntemin validasyonu için ilk olarak Lambert-Beer yasasına uyan çalışma aralığı belirlenmiştir. Bu aralığın 0.005-0.16 mmol.L-1 olduğu bulunmuştur. Bu çalışma aralığında 0.9987 korelasyon katsayısı ile elde edilen kalibrasyon eğrisinin denklemi y = 6.9023x-0.0147'dir. Bu yöntemde tespit limiti ve kantitatif limit sırasıyla 0.0013 mmol.L-1 ve 0.0045 mmol.L-1 olarak bulunmuştur. Önerilen yöntemin PRX'in tablet formülasyonuna uygulanabileceği tespit edilmiştir.

Keywords

Paroksetin HCl, Spektrofotometrik tayin, Bakır, Ditiyokarbamat

Supporting Institution

Dicle Üniversitesi Bilimsel Araştırma Koordinatörlüğü

Project Number

ECZACILIK:19.001

A Different Analytical Method for Determination of Paroxetine HCl by UV-VIS

Abstract

For the determination of Paroxetine HCl (PRX) from tablet form a sensitive, easy and selective spectrophotometric method was developed. This method is based on the formation of a colored Cu-dithiocarbamate derivative complex on the basis of the secondary amine group in the structure of the drug substance. The colored complex gives maximum absorbance at 435 nm in methylisobuthylketone by UV-VIS spectrometer. In the method, the effect of solvent, NH3 concentration, CS2 concentration, Cu2+ concentration and reaction time were investigated. Then, the method was statistically validated. For the validation of the method, the working range that obeyed to the Lambert-Beer law was determined, firstly. The range was found to be 0.005-0.16 mmolL-1. The equation of the calibration curve obtained with 0.9987 correlation coefficient in the specified working range is y = 6.9023x-0.0147. In the method, limit of detection and limit of quantitative were found to be 0.0013 mmolL-1, and 0.0045 mmolL-1, respectively. It has been seen that the proposed method is applicable to tablet formulation of PRX.

Keywords

Paroxetine HCl, copper, Spectrophotometric determination, dithiocarbamate

Project Number

ECZACILIK:19.001

References

• Mikus P., Novotny L. 2015. On the Importance of Pharmaceutical Analysis, Research & Reviews: Journal of Pharmaceutical Analysis, 4, 3: 13-14
• Palak Kriti and Kanchan Kohli. 2016. Development of Ultraviolet Spectroscopic And Thin Layer Chromatography Method Of Broccoli Extract, Indo American Journal of Pharmaceutical Sciences, 3, 10: 1309-1314
• Siladitya B., Subhajit G., Fahad A., Saayak S., Sritoma B. 2012. UV-Visible Spectrophotometric Method Development and Validation of Assay of Paracetamol Tablet Formulation, Analytical & Bioanalytical Techniques, 3: 6
• Kalia S.B. Kaushal, G. Kumar, M. Cameotra, S.S. Sharma, A Verma, M.L., Kanwar, S.S. 2009. Antimicrobial and toxicological studies of some metal complexes of 4- methylpiperazine-1-carbodithioate and phenanthroline mixed ligands, Brazilian Journal of Microbiology 40: 916–922.
• Kanchi S. Singh, P. Bisetty, K. 2014. Dithiocarbamates as hazardous remediation agent: a critical review on progress in environmental chemistry for inorganic species studies of 20th century, Arabian Journal of Chemistry 7: 11–25
• Wanabe, T., Tokunaga R., Iwanaha T., Tati M., Ikeda M. 1978. Determination of Urinary Manganese by the Direct Chelation-extraction method and Flameless Atomic Absorption spectrophotometry, British Journal of Industrial Medicine, 35: 73-77
• Alpdogan G. ve Sungur S. 1999. AAS and spectrophotometric methods for the determination metoprolol tartrate in tablets, Spectrochimica Acta Part A, 55: 2705-2709, DOI: 10.1016/S1386-1425(99)00121-3
• Golcu A., Dolaz M., Serin S. 2001. Spectrophotometric Determination of Propranolol as Cu (II), Ni (II) and Co (II) Dithiocarbamate Complexes, Turk Journal of Chemistry, 25: 485-490
• Iturbide-Casas M., Molina-Recio G., Camara-Martos F. 2018. Manganese Preconcentration and Speciation in Bioaccessible Fraction of Enteral Nutrition Formulas by Cloud Point Extraction and AtomicAbsorbtion Spectroscopy, Food Analytical Methods 11: 2758-2766
• FDA, Paxil, Prescribing Information, Available from: https://www.accessdata.fda.gov, cited date: 2019.11.29
• Arshiya F., Sayaji R. and Venkateshwarlu G. 2011. Spectrophotometric determination of drugs using 2,3 Dichloro 5,6 dicyano-p-Benzoquinone as Analytical reagent, International Journal of Chemistry Tech Research, 3, 4: 1769-1780
• Nouws H. P. A., Delerue-Matos C., Barros A. A., Rodrigues J. A. 2006. Electroanalytical determination of paroxetine in pharmaceuticals, Journal of Pharmaceutical and Biomedical Analysis, 42: 341–346
• Zheng M., Zhang C., Wang L., Wang K., Kang W., Lian K., Li H. 2021. Determination of nine mental drugs in human plasma using solid-phase supported liquid-liquid extraction and HPLC-MS/MS, Microchemical Journal, 160:105647
• Caris J. A., Andréa R. Chaves and Maria Eugênia C. Queiroz, 2012. Evaluation of Solid-Phase Microextraction using a Polythiophene Film and Liquid Chromatography with Spectrophotometric Detection for the Determination of Antidepressants in Plasma Samples, Journal of Brazilian Chemistry Society, 23, 1: 57-64
• Oztunc A., Onal A., Erturk S. 2002. 7,7,8,8-Tetracyanoquinodimethane as a new derivatization reagent for high-performance liquid chromatography and thin-layer chromatography: rapid screening of plasma for some antidepressants, Journal of Chromatography B, 774: 149–155
• Omar M. A., Abdelmageed O. H., Derayea S. M., Attia T. Z. 2017. Spectrofluorimetric protocol for antidepressant drugs in dosage forms and human plasma through derivatization with dansyl chloride, Arabian Journal of Chemistry, 10: 3197-3206
• Ibrahim A. Darwish, Sawsan M. Amer, Heba H. Abdine and Lama I. Al-Rayes. 2008. New Spectrofluorimetric Method with Enhanced Sensitivity for Determination of Paroxetine in Dosage Forms and Plasma, Analytical Chemistry Insights, 3: 145–155
• Sharma M. C., Sharmaa S. 2010. Alidated Sımultaneous Spectrophotometrıc Estimation Of Paroxetine Hcl Bulk And Tablet Dosage Form Using Ferric Chloride, Journal Of Optoelectronics And Biomedical Materials 2, 4: 185 – 189
• Walash M. I., El-Enany N., Belal F., El-Mansi H. 2010. Spectrophotometric Determination Of The Antidepressants Sertraline And Paroxetine Hcl Using 2,4-Dinitrofluorobenzene, International Journal of Biomed Science, 6, 3: 252–259.
• Golcu A. and Yavuz P. 2008. Spectral, Analytical, Thermal, and Antimicrobial Studies of Novel Sodium 2-[4 (2-Hydroxy-3-Izopropylaminopropoxy) Phenyl] Acetamide (Atenolol) Dithiocarbamate and its Divalent Transition Metal Complexes, Russian Journal of Coordination Chemistry, 34, 2:106–114
• El-Ries M. A., Abou-Attia F. M., Ibrahim S. A. 2000. AAS and Spectrophotometric Determination of Propranolol HCl and Metoprolol Tartarat, Journal of Pharmaceutical and Biomedical Analysis, 24: 179-187
• Gunduz T. 2010. Statistics for Chemists, Second edition, Gazi Publishing Trade Limited Company, Ankara, Turkey
• ICH-Q2. 2005. International Conference on Harmonisation of Technical Requirements for Registration Of Pharmaceuticals For Human Use. Validation of analytical Procedures: Text And Methodology Q2 (R1), Step 4 Version
• Onal, A., Oztunc A, Kepekci S. 2005. Spectrophotometric Methods For The Determination Of The Antidepressant Drug Paroxetine Hydrochloride in Tablets, Journal Of Aoac International, 88, 2: 490-495
• Darwish I. A., Heba H. A., Sawsan M. A., Lama I. Al-R. 2009. Simple Spectrophotometric Method For Determination Of Paroxetine in Tablets Using 1,2-Naphthoquinone-4-Sulphonate As A Chromogenic Reagent, International Journal Of Analytical Chemistry, 1-8
• Nwodo N. J., Ibezim A. 2013. Simple Spectrophotometric Method For Determination Of Paroxetine In Tablets Using Chloranilic Acid As Chromogenic Reagent, World Journal Of Pharmaceutical Research, 3, 1: 126-138
• Elqudaby H. M., Fragb E. Y. Z, Mohamed G. G. and Mohamed M. A. 2012. Optimized And Validated Spectrophotometric Methods For The Determination Of Clomipramine And Paroxetine Hydrochloride In Drug Formulations, International Journal Of Research in Ayurveda And Pharmacy, 3, 4: 537-542