Abstract
A sensitive and simple spectrofluorimetric method has been developed and validated for the determination of the antidepressant paroxetine HCl (PXT) in its dosage forms. The method was based on coupling reaction of PXT with 4-chloro-7-nitrobenzo-2- oxa-1,3-diazole (NBD-Cl) in an alkaline medium (pH 8) to form a highly fluorescent derivative that was measured at 530 nm after excitation at 460 nm. The factors affecting the formation and stability of the reaction product were carefully studied and optimized. The fluorescence–concentration plot is rectilinear over the range 0.2-6 μg/mL with LOD of 0.08 μg/mL and LOQ of 0.24 μg/mL respectively. The method was applied to the analysis of commercial tablets and the results were in good agreement with those obtained using the reference method. The mean percentage recoveries for paxetin and xandol tablets were 101.27 ± 1.79 and 101.33 ± 1.19 respectively. A proposal of the reaction pathway was postulated.
Similar content being viewed by others
References
The British Pharmacopoeia. The stationary office: London, (2007), Electronic version
Sweetman SC (ed) (2009) Martindale: the complete drug reference. Pharmaceutical, London, Electronic version
Zainaghi IA, Lanchote VL, Queiroz RHC (2003) Determination of paroxetine in geriatric depression by high performance liquid chromatography. Pharmacol Res 48:217–221
Zhu Z, Neirinck L (2002) High-performance liquid chromatography-mass spectrometry method for the determination of paroxetine in human plasma. J Chromatogr B 780:295–300
Massaroti P, Cassiano NM, Durate LF (2005) Validation of a selective method for determination of paroxetine in human plasma by LC-MS/MS. J Pharm Pharm Sci 8:340–347
Jheee OH, Seo HK, Lee MH (2007) Determination of paroxetine in plasma by liquid chromatography coupled to tandem mass spectrometry for pharmacokinetic and bioequivalence studie. Arzeneimittel-Forschung 57:455–461
British Pharmacopoeia (2003) The Stationary Office, London, UK
Nouws HPA, Delerue-Matos C, Barros AA, Rodrigues JA (2006) Electroanalytical determination of paroxetine in pharmaceuticals, J Pharm Biomed Anal 42:341–346
Erk N, Biryol J (2003) Voltammetric and HPLC techniques for the determination of paroxetine hydrochloride. Pharmazie 58:699–704
Eap CB, Bouchoux G, Amey M, Cochard N, Savary L, Baumann P (1998) Simultaneous determination of human plasma levels of citalopram, paroxetine, sertraline, and their metabolites by gas chromatography-mass spectrometry. J Chromatogr Sci 36:365–371
Hans JL, Werner W, Günter F (2002) Improved sample preparation for the quantitative analysis of paroxetine in human plasma by stable isotope dilution negative ion chemical ionization gas chromatography-mass spectrometry. J Chromatogr B 779:353–357
Chien L, Emily SG, Sidney HK, Alan N, Ronald TC, Glen BB (2000) Determination of paroxetine levels in human plasma using gas chromatography with electron-capture detection. J Chromatogr B 749:275–279
Labat L, Deveaux M, Dallet P, Dubost JP (2002) Separation of new antidepressants and their metabolites by micellar electrokinetic capillary chromatography. J Chromatogr B 773:17–23
Onal A, Kepekçi SE, Oztunç A (2005) Spectrophotometric methods for the determination of the antidepressant drug paroxetine hydrochloride in tablets. J AOAC Int 88:490–495
Darwish IA, Refaat IH (2006) Spectrophotometric analysis of selective serotonin reuptake inhibitors based on formation of charge-transfer complexes with tetracyanoquinodimethane and chloranilic acid. J AOAC Int 89:326–333
Darwish IA (2005) Development and validation of spectrophotometric methods of fluoxetine, sertraline and paroxetine in pharmaceutical dosage forms. J AOAC Int 88:38–45
Darwish IA, Abdine H, Amer S, Al-Rayes L (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, vol. 2009: ID 237601
Taha EA, Salama NN, Fattah L (2006) Spectrofluorimetric and spectrophotometric stability-indicating methods for determination of some oxicams using 7-chloro-4-nitrobenz-2-oxa-1, 3-diazole(NBD-Cl). Chem Pharm Bull (Tokyo) 54:653–658
El-Enany N, El-Sherbiny D, Belal F (2007) Spectrophotometric, spectrofluorometric and HPLC determination of desloratadine in dosage forms and human plasma. Chem Pharm Bull (Tokyo) 55:1662–1670
Saleh HM, El-Henawee MM, Ragab GH, El-Hay SS (2007) Utility of NBD-Cl for the spectrophotometric determination of some skeletal muscle relaxant and antihistaminic drugs. Spectrochim Acta 67:1284–1289
Olojo RO, Xia RH, Abramson JJ (2005) Spectrophotometric and fluorometric assay of superoxide ion using 4-chloro-7-nitrobenzo-2-oxa-1, 3-diazole. Anal Biochem 339:338–344
Miyano H, Toyo’oka T, Miyano H (1985) Anal Chim Acta 170:81
Guidance for Industry; Q2B of Analytical Procedures: Methodology; International Conference on Hormonization (ICH), November (1996). http://www.fda.gov/eder/guidance/1320fnl.pdf (accessed September 1, 2004)
Miller JN, Miller JC (2005) Statistics and chemometrics for analytical chemistry, 5th edn. Prentice Hall, England, 256
Rose (2006) J Advanced Physico-Chemical Experiments. Pitman, London, 1964
El-Enany N, Belal F, Rizk M (2006) Kinetic Spectrophotometric Determination of Isoxsuprine in Dosage Forms Through Derivatization with 4-chloro-7- nitrobenzo-2-oxa-1, 3- diazole (NBD-Cl). Sci Pharm 74:99–119
Crampton MR, Delaney J, Rabbitt LC (1999) Unusual reaction of 4-nitrobenzofurazan with amines. J Chem Soc Perkin Trans 2:2473
Moutires G, Pinson J, Terrier F, Goumont R (2001) Chem Eur J 7:1712
Makosza M, Winiarski J (1987) Acc Chem Res 20:282–289
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Walsh, M., Belal, F., El-Enany, N. et al. Spectrofluorimetric Determination of Paroxetine HCl in Pharmaceuticals via Derivatization with 4-chloro-7- nitrobenzo-2-oxa-1,3-diazole (NBD-Cl). J Fluoresc 21, 105–112 (2011). https://doi.org/10.1007/s10895-010-0693-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10895-010-0693-2