SYNCHRONOUS FLUORESCENCE SPECTROSCOPY COUPLED WITH CONTINUOUS WAVELET TRANSFORMS AND SAVITZKY-GOLAY DERIVATIZATION TECHNIQUE FOR THE SIMULTANEOUS DETERMINATION OF TADALAFIL AND DAPOXETINE HCl.

  • Maha Hegazy Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, EGYPT
  • Amira Kessiba
  • Mohamed Abdelkawy
  • Ahmed Elgendy

Abstract

Objective: A novel combination of Tadalafil (TAD) and Dapoxetine HCl (DAP) has been recently introduced into the market for the treatment of premature ejaculation. The aim of this work is the development and validation of simple, sensitive and accurate analytical methods for the determination of TAD and DAP in their binary mixture without prior separation.

Methods: Synchronous fluorescence spectroscopic (SFS) methods coupled with continuous wavelet transforms (CWT) and Savitzky-Golay (SAVGOL) derivatization technique have been developed.

Results: Under optimum conditions, TAD and DAP were determined in the concentration ranges of 0.01–3 µg/ml and 0.01–1.2 µg/ml, respectively.

Conclusion: The developed methods have the requisite accuracy, selectivity, sensitivity and precision and were satisfactorily applied for the simultaneous determination of TAD and DAP in bulk powder and pharmaceutical preparations. The results obtained for the analysis of both drugs in their pure forms by the proposed methods were statistically compared to those obtained by applying a reported high performance liquid chromatographic method (HPLC) method. The statistical comparison showed that there is no significant difference between the proposed methods and the reported one with respect to accuracy and precision.

Keywords: Synchronous fluorescence spectroscopy, Tadalafil, Dapoxetine HCl, Continuous wavelet transforms, Savitzky-Golay technique

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References

1. Patra D, Mishra AK. Recent developments in a multi-component synchronous fluorescence scan analysis. Trends Anal Chem 2002;21:787-98.
2. Vo-Dinh T. Synchronous luminescence spectroscopy: methodology and applicability. Appl Spect 1982;36:576-81.
3. Vo-Dinh T. Multicomponent analysis by synchronous luminescence spectrometry. Anal Chem 1978;50:396-401.
4. Rubio S, Gomez-Hens A, Valcarcel M. Analytical applications of synchronous fluorescence spectroscopy. Talanta 1986;33:633-40.
5. Shao XG, Leung AK, Chau FT. Wavelet: a new trend in chemistry. Acc Chem Res 2003;36:276-83.
6. “Wavelets in Chemistry” Elseveir Press: Amsterdam, The Netherlands; 2000.
7. Dinc E, Baleanu D. Multicomponent resolution of binary mixtures by using continuous wavelet transform. J AOAC Int 2004;87:360-5.
8. Dinc E, Ozdemir A, Baleanu D. Comparative study of the continuous wavelet transform, derivative, and partial least squares methods applied to the overlapping spectra for the simultaneous quantitative resolution of ascorbic acid and acetylsalicylic acid in effervescent tablets. J Pharm Biom Anal 2005;37:569-75.
9. Dinc E, Baleanu D, Aboul-Enein HY. Wavelet analysis for the multicomponent determination in a binary mixture of caffeine and propyphenazone in tablets. Il Farmaco 2004;59:335-42.
10. Gao L, Ren S. Simultaneous multicomponent analysis of overlapping spectrophotometric signals using a wavelet-based latent variable regression. Spectrochim Acta Part A 2008;71:959-64.
11. Afkhami A, Targhat MA. Application of continuous wavelet transformation to the simultaneous kinetic determination of binary mixtures. Talanta 2009;78:424-31.
12. Savitzky A, Golay MJF. Smoothing and differentiation of data by simplified least squares procedures. Anal Chem 1964;36:1627-39.
13. Savitzky A. A historic collaboration. Anal Chem 1989; 61:921A-3A.
14. Steinier J, Termonia Y, Deltour J. Smoothing and differentiation of data by the simplified least square procedure. Anal Chem 1972;44:1906-9.
15. Madden HH. Comments on the Savitzky-Golay convolution method for least-squares-fit smoothing and differentiation of digital data. Anal Chem 1978;50:1383-6.
16. “The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals” Division of Merck and Co., Whitehouse station, NJ, USA; 2006.
17. “Martindale: The Complete Drug Reference” Pharmaceutical Press, London, UK; 2007.
18. Wright PJ. Comparison of phosphodiesterase type 5 (PDE5) inhibitors. Int J Clin Pract 2006;60:967-75.
19. Brock GB, McMahon GG, Chen KK, Costigan T, Shen W. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol 2002;168:1332-6.
20. Carson CC, Rajfer J, Eardley I, Carrier S, Denne JS. The efficacy and safety of tadalafil: an update. BJU Int 2004;93:1276-81.
21. Lewis RW, Sadovsky R, Eardley I, O’Leary M, Seftel A. The efficacy of tadalafil in clinical populations. J Sex Med 2005;2:517-31.
22. Gupta M, Kovar A, Meibohm B. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharm 2005;45:987-1003.
23. Gengo PJ, Giuliano F, McKenna K. Monoaminergic transporter binding and inhibition profile of dapoxetine, a medication for the treatment of premature ejaculation. J Urol 2005;173:239-44.
24. Kendirci M, Salem E, Hellstrom WJ. Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation. Ther Clin Risk Manage 2007;2:277-89.
25. Hiemke C, Harter S. Pharmacokinetics of selective serotonin reuptake inhibitors. Pharmacotherapy 2000;85:11-28.
26. Modi NB, Dresser MJ, Simon M, Lin D, Gupta S. Single and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharm 2006;46:301-9.
27. Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, et al. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind randomized controlled trials. Lancet 2006;368:929-37.
28. Buvat J, Tesfaye F, Rothman M, Rivas DA, Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol 2009;55:957-68.
29. Dresser MJ, Desai D, Gidwani S, Seftel AD, Modi NB. Dapoxetine, a novel treatment for premature ejaculation, does not have pharmacokinetic interactions with phosphodiesterase-5 inhibitors. Int J Impotence Res 2006;18:104-10.
30. Giri AD, Bhusari VK, Dhaneshwar SR. Validated HPLC method for simultaneous quantitation of tadalafil and dapoxetine hydrochloride in bulk drug and formulation. Int J Pharm Pharm Sci 2012;4:654-8.
31. Rajeshwari M, Chenthilnathan A, Rama K. Validated RP-HPLC method for simultaneous estimation of tadalafil and dapoxetine hydrochloride in combined pharmaceutical dosage forms. Int J Pharm Biol Sci 2014;4:72-82.
32. Amin GA, Chapla B, Pandya A, Kakadiya J, Baria D. Development and validation of dual wavelength UV spectrophotometric method for simultaneous estimation of Tadalafil and dapoxetine hydrochloride in their combined tablet dosage form. Int J Pharm Res Bio-Sci 2012;1:247-55.
33. Kavitha A, Vijaya DD, Hima SB, Eshvendar K, Khaleel N, Pani ADK. Forced degradation studies, quantification and in-vitro dissolution studies of tadalafil by spectrofluorimetry. Asian J Pharm Clin Res 2013;6:326-9.
34. Farthing CA, Farthing DE, Koka S, Larus T, Fakhry I, Xi L, et al. Simultaneous assay of sildenafil and desmethyl sildenafil in human plasma using liquid chromatography–tandem mass spectrometry on silica column with aqueous–organic mobile phase. J. Chromatogr B: Anal Technol Biomed Life Sci 2010;878:2891-5.
35. Soliman SM, El-Agizy HMY, El-Bayoumi A. Derivative synchronous fluorescence spectroscopy for the simultaneous determination of dapoxetine hydrochloride and vardenafil in binary mixtures. J Appl Spectrosc 2014;81:509-18.
36. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva; 2005.
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How to Cite
Hegazy, M., A. Kessiba, M. Abdelkawy, and A. Elgendy. “SYNCHRONOUS FLUORESCENCE SPECTROSCOPY COUPLED WITH CONTINUOUS WAVELET TRANSFORMS AND SAVITZKY-GOLAY DERIVATIZATION TECHNIQUE FOR THE SIMULTANEOUS DETERMINATION OF TADALAFIL AND DAPOXETINE HCl.”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 4, Apr. 2016, pp. 32-38, https://innovareacademics.in/journals/index.php/ijpps/article/view/8699.
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