Stability-Indicating Micelle-Enhanced Spectrofluorimetric Method For Determination of Tamsulosin Hydrochloride In Dosage Forms.
DOI:
https://doi.org/10.24297/jac.v11i2.6692Keywords:
Tamsulosin hydrochloride, sodium dodecyl sulphate, micellar systemAbstract
A rapid, simple and highly sensitive spectrofluorimetric method is developed for the determination of Tamsulosin hydrochloride (Tams.HCl) in pharmaceutical formulations. The proposed method is based on investigation of the fluorescence spectral behavior of Tams.HCl in a sodium dodecyl sulphate (SDS) micellar system. In aqueous solution of Tris buffer of pH 7±0.2, SDS causes marked enhancement in the fluorescence intensity of Tams.HCl (about +110%). The fluorescence intensity is measured at 328 nm after excitation at 280 nm and the fluorescence-concentration plots are rectilinear over the range 0.1-1.2 µg ml-1, with lower detection limit of 0.027 µg ml-1 and quantification limit of 0.09 µg ml-1. The method is successfully applied to the analysis of the studied drug in its commercial capsules, and the results are in good agreement with those obtained with the official method. The application of the proposed method is extended to stability studies of Tamsulosin hydrochloride after exposure to different forced degradation conditions, such as acidic, alkaline and oxidative conditions, according to ICH guidelines.
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References
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2- Sweetman S. C. Martindale : the complete drug reference , Thirty-third Edition, Pharmaceutical Press, Great Britain, (2002).
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4- Sibel A O, zkan a , Bengi Uslu a, Hassan Y, Aboul-Enein b., Voltammetric investigation of Tamsulosin. Talanta ,61, 2003, 147-/156.
5- Nilam A.Gadhave, Minal R. Ghante, Atul D. Nikam, Sanjay D. Sawant, Simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage form by UV spectroscopy method. Journal of Pharmacy Research,4(8), 2011, 2672-2674.
6- Qi M L, Wang P, Cong R H, Determination of the enantiomers of tamsulosin hydrochloride and its synthetic intermediates by chiral liquid chromatography. Chromatographia, 59(3-4) , 2004, 251-254.
7- Zhang ZF, Yang GL, Liang GJ , Liu HY, Chen Y, Chiral separation of tamsulosin isomers by HPLC using cellulose Tris (3,5-dimethylphenylcarbamate) as a chiral stationary phase. J.Pharm. Biomed.Anal., 34(3), 2004, 689-693.
8- Aboul-Enein HY, Hussein RF, Radwan MA, Yusuf A, Al -Ahmadi W, Al-Rawithi S, Tamsulosin dissolution from pharmaceutical dosage forms using an automated HPLC system. J.Liq.Chromatogr.Relat.Technol., 26(7), 2003,1109-1116.
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10- Macek J, Kl´ýma J, Ptcek P, Rapid determination of tamsulosin in human plasma by high-performance liquid chromatography using extraction with butyl acetate. J. Chromatogr. B., 809, 2004, 307–311.
11- Sangita Agarwal K ,Veeran Gowda , Amlan Kanti Sarkar, Debotri Ghosh, Uttam Bhaumik ,Tapas Kumar Chattaraj, Tapan Kumar Pal, Simultaneous Determination of Tamsulosin and Dutasteride in Human Plasma by LC–MS–MS. Chromatographia, 67, 2008, 893-903.
12- Pekka Keski-Rahkonen , Olavi P¨arssinen , Esa Lepp¨anen , Timo Mauriala ,Marko Lehtonen , Seppo Auriola, Determination of tamsulosin in human aqueous humor and serum by liquid chromatography–electrospray ionization tandem mass spectrometry. J.Pharm.Biomed.Anal., 43, 2007, 606–612.
13- Qi ML, Wang P, Liu LH, Determination of tamsulosin in dog plasma by liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry. J.Chromatogr.B.Anal.Technol.Biomed.Life.Sci., 805(1), (2004), 7-11.
14- Ding L, Li LM, Tao P, Yang J, Zhang ZX, Quantitation of tamsulosin in human plasma by liquid chromatographyelectrospray ionization mass spectrometry .J.Chromatogr. B.Anal.Technol.Biomed.Life.Sci., 767(1), 2002, 75-81.
15- Matsushima H, Takanuki K, Kamimura H, Watanabe T, Higuchi S, Highly sensitive method for the determination of tamsulosin hydrochloride in human plasma dialysate, plasma and urine by high-performance liquid chromatographyelectrospray tandem mass spectrometry J.Chromatogr.B.Biomed.Appl. 695(2), 1997, 317-327.
16- Andrea KavalÃrová , Marie Pos pÃÅ¡ ilová , Rolf KarlÃc¡ek , Enantiomeric purity determination of tamsulosin by capillary electrophoresis using cyclodextrins and a polyacrylamide-coated capillaryIl Farmaco, 60, 2005, 834–839.
17- Hertz P. M. R. and McGown L. B., Organized media for fluorescence analysis of complex samples: comparison of bile salt and conventional detergent micelles in coal liquids. Anal.Chem., 64(23) ,1992, 2920.
18- Wehry E L, in Frank A.Settle, ed., Handbook of Instrumental Techniques for Analytical Chemistry.Chapter 26, Molecular Fluorescence and Phosphorescence Spectrometry. Prentice Hall,New Jersy. U.S.A.(1997).
19- Dorsey JG, Micellar liquid chromatography. Adv. Chromatogr. 27, (1987),198.
20-Alarfaj NA, Aly FA, Micelle-Enhanced Spectrofluorimetric Method for Determination of Cholesterol -Reducing Drug
Ezetimibe in Dosage Forms. J. Fluoresc. 2011.
21-Walash MI, Belal F, El-Enany N, Eid M, El-Shaheny RN, Stability-indicating micelle-enhanced spectrofluorimetric
method for determination of loratadine and desloratadine in dosage forms. Luminescence. 2011.
22-Culzoni MJ, Aucelio RQ, Escandar GM, Spectrofluorimetry in organized media coupled to second-order multivariate
calibration for the determination of galantamine in the presence of uncalibrated interferences. Talanta., 82(1), 2010,
325-32.
23-Walash MI, Belal F, El-Enany N, Abdelsalam A, Spectrofluorometric determination of verapamil hydrochloride in pharmaceutical preparations and human plasma using organized media: application to stability studies. J. AOAC. Int,. 89(6), 2006, 1565-72.
24-Ocaña JA, Barragán FJ, Callejón M, Spectrofluorimetric and micelle-enhanced spectrofluorimetric determination of gatifloxacin in human urine and serum. J. Pharm. Biomed. Anal., 37(2), 2005, 327-32.
25- Ocana JA, Barragan FJ, Callejon M, Fluorescence and terbium-sensitized luminescence determination of garenoxacin in human urine and serum. Talanta., 63(3), 2004, 691-697.
26- Arancibia J A , Escandar G M, Determination of naproxen in pharmaceutical preparations by room-temperature phosphorescence. A comparative study of several organized media. Analyst., 126 (6), 2001, 917-22.
27- González JA, Callejón Mochón M, de la Rosa FJ, Spectrofluorimetric determination of levofloxacin in tablets, human urine and serum. Talanta., 52(6), 2000, 1149-56.
28- Sbai M, Lyazidi SA, Lerner DA, del Castillo B, Martin MA, Use of micellar media for the fluorimetric determination of ellipticine in aqueous solutions. J. Pharm. Biomed. Anal. ,14(8-10), 1996, 959-65.
29- Sancenón J , de la Guardia M, Micellar enhanced fluorimetric determination of carbendazim in natural waters Anal. Chim. Acta., 287(1-2), 1994, 49-5.
30- Manuel V. Galdú, Miguel de la Guardia , Lorenzo Braco, Influence of anionic surfactants on the sensitisation of the fluorimetric determination of fenproporex Analyst.. 112, 1987, 1047-1050.
31- Perrin, D.D. and Dempsey B. Buffers for pH and Metal Ion Control. Chapman and Hall, London ; Wiley , New York. (1974), 153.
32- Hinze W L, Singh HN, Baba Y, Harvey NG, Micellar enhanced analytical fluorimetry. Trends. Anal. Chem. 3, 1984, 193–9.
33- Ohannesian L. Handbook of pharmaceutical analysis. Marcel Dekker: New York, Basel, 2002; electronic version.
34- ICH Harmonized Tripartite Guideline, Validation of analytical procedures: Text and methodology, Q2(R1), Current Step 4 Version, Parent Guid lines ON Methodology Dated November 6, 1996, Incorporated in November 2005. http://www.Ich.org/LOB/media/MEDIA417.pdf.
35- Miller JC and Miller JN, Statistics and Chemometrics for Analytical Chemistry, Fifth Eidition . Prentice Hall, Harlow. England. (2005).
36- Tang B, Wang X, Jia B, Niu J, Ying Wei Y, Chen Z, Wang Y, Simple,rapid, and sensitive spectrofluorimetric
determination of zaleplon in micellar medium. Anal. Lett. 36, (2003), 2985–97.
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Published
2015-01-24
How to Cite
Elshahed, M. E., & Habib, I. (2015). Stability-Indicating Micelle-Enhanced Spectrofluorimetric Method For Determination of Tamsulosin Hydrochloride In Dosage Forms. JOURNAL OF ADVANCES IN CHEMISTRY, 11(2), 3513–3531. https://doi.org/10.24297/jac.v11i2.6692
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