Accessible Unlicensed Requires Authentication Published by De Gruyter November 30, 2021

Micellar-Enhanced Spectrofluorimetric Method for Quantification of Diclofenac Potassium in Pure Form, in Pharmaceutical Preparations and Human Plasma

Mit Mizellen unterstützte spektrofluorimetrische Methode zur Quantifizierung von Diclofenac-Kaliumsalz in reiner Form, in pharmazeutischen Zubereitungen und in menschlichem Plasma
Muhammad Naeem Khan, Irum, Saba Gul, Muslima and Muhammad Mursaleen

Abstract

A rapid, simple and economical spectrofluorimetric method for the determination of diclofenac potassium in pure form, in pharmaceutical preparations and in human plasma has been developed. The method is based on the enhancement of the fluorescence signal of diclofenac potassium by the addition of sodium dodecyl sulphate in McIvaine buffer with a pH of 5. Different experimental conditions such as buffer type, pH, type and concentration of surfactants were investigated. The fluorescence intensity of the solution was recorded at 361 nm after excitation at 243 nm. The method shows linearity in the concentration range of 0.2 μg mL–1–10 μg mL–1 with a good correlation coefficient of 0.997. The relative standard deviation value was 3.62 (n = 7). The limit of detection and limit of quantification were calculated to be 2.84 × 10–3 μg mL–1 and 9.47 × 10–3 μg mL-1, respectively. The effect of excipients and co-administrated drugs was investigated and no interference was observed. The method was successfully applied for the determination of diclofenac potassium in pure form, in pharmaceutical products and in human plasma. The percentage recoveries obtained ranged from 100.25% to 102.16% for pure form and 97.50% to 102.00% for pharmaceutical products and from 98.50% to 101.67% for human plasma.

Zusammenfassung

Es wurde ein schnelles, einfaches und wirtschaftliches spektrofluorimetrisches Verfahren zur Bestimmung von Diclofenac-Kaliumalz in reiner Form, in pharmazeutischen Produkten und in menschlichem Plasma entwickelt. Die Methode basiert auf der Verstärkung des Fluoreszenzsignals von Diclofenac-Kaliumsalz durch die Zugabe von Natriumdodecylsulfat in McIvaine-Puffer mit einem pH-Wert von 5. Es wurden verschiedene Versuchsbedingungen wie Pufferart, pH-Wert, Art und Konzentration der Tenside untersucht. Die Fluoreszenzintensität der Lösung wurde bei 361 nm und nach Anregung bei 243 nm aufgezeichnet. Die Methode zeigt lineares Verhalten im Konzentrationsbereich von 0,2 μg mL–1–10 μg mL–1 mit einem guten Korrelationskoeffizienten von 0,997. Die relative Standardabweichung betrug 3,62 (n = 7). Die berechnete Nachweis- und Bestimmungsgrenze betrug 2,84 × 10–3 μg mL–1 bzw. 9,47 × 10–3 μg mL–1. Die Einfluss von Hilfsstoffen und gleichzeitig verabreichten Arzneimitteln wurde untersucht und es wurden keine Interferenzen festgestellt. Die Methode wurde erfolgreich für die Bestimmung von Diclofenac-Kalium in reiner Form, in pharmazeutischen Produkten und in menschlichem Plasma eingesetzt. Die erzielten prozentualen Wiederfindungen lagen zwischen 100,25% und 102,16% für die reine Form und zwischen 97,50% und 102,00% für pharmazeutische Produkte sowie zwischen 98,50% und 101,67% für Humanplasma.


Muhammad Naeem Khan Department of Chemistry Bacha Khan University 24420 Charsadda Pakistan

References

1 Sweetman S.: editor. Analgesics Anti-inflammatory Drugs and Antipyretics. In: Martindale-The Complete Drug Reference. 36th ed., London: Pharmaceutical Press, (2009) 44. Search in Google Scholar

2 Remington, J. P. and Gennaro A. R.: The Science and Practice of Pharmacy, 19th Edition Mack Pub (1995). Search in Google Scholar

3 Tripathi, K. D.: Essentials of Medical Pharmacology, 7th Ed. Jaypee Brothers Medical Publishers Pvt Ltd, New Delhi, India, (2003) 178. Search in Google Scholar

4 Foye, W. O., Lamke, T. L. and Williams, D. A.: Principles of Medicinal Chemistry, 4th Edition B. I. Waverly Pvt. Ltd., New Delhi, India, (1995) 558,. DOI:10.1021/jm960031y Search in Google Scholar

5 Rubim, A. M., Rubenick, J. B., Laporta, L. V. and Rolim, C. M. B.: A simple method for the quantification of diclofenac potassium in oral suspension by high-performance liquid chromatography with UV-detection, Braz. J. Pharm. Sci. 49 (2013) 589–597. DOI:10.1590/S1984-82502013000300021 Search in Google Scholar

6 Kumar, R, S., Karthikeyan, C., Moorthy, N. S. H. N. and Trivedi, P.: New spectrophotometric methods applied to the simultaneous determination of diclofenac potassium and tizanidine, Indian J. Pharm. Sci. 73 (2011) 300–302. DOI:10.4103/0250-474X.26664 Search in Google Scholar

7 Ciapina, E. G., Santini, A. O., Weinert, P. L., Gotardo, M. A., Pezza, H. R. and Pezza, L.: Spectrophotometric determination of diclofenac in pharmaceutical preparations assisted by microwave oven, J. Eclet. Quím. 30 (2005) 29–36. DOI:10.1590/S0100-46702005000100004 Search in Google Scholar

8 Khatal, L., Mahadik, M., Kamble, A. Y. and Dhaneshwar, S. R.: Validated HPTLC method for simultaneous quantitation of paracetamol, diclofenac potassium, and famotidine in tablet formulation, J.AOAC Int. 93 (2010) 765–770. PMid:20629373; DOI:10.1093/jaoac/93.3.765 Search in Google Scholar

9 El-Yazbi, F. A., Amin, O. A., El Kimary, E., Khamis, E. F. and Younis, S. E.: HPTLC and spectrophotometric estimation of febuxostat and diclofenac potassium in their combined tablets, J. Chromatogr. Sci. 54 (2016) 1146–1152. PMid:27406127; DOI:10.1093/chromsci/bmw091 Search in Google Scholar

10 Panda, S. S., Patanaik, D., Bera, V. V. and Kumar, R.: New stability-indicating RPHPLC method for determination of diclofenac potassium and metaxalone from their combined dosage form, Sci. Pharm. 80 (2012) 127–137,. PMid:22396909; DOI:10.3797/scipharm.1109-16 Search in Google Scholar

11 Rele, R. V., Parab, J. M., Mhatre, V. V. and Warkar, C. B.: \Simultaneous RPHPLC determination of diclofenac potassium and fematodine in pharmaceutical preparations, Research J. Pharm. Tech. 4 (2011) 638–641. DOI:10.5958/0974-360X.2016.00006.8 Search in Google Scholar

12 Dongala, T., Palakurthi, A. K., Velaveni, K. K. and Katari, N. K.: Development and validation of RP-HPLC method for simultaneous determination of diclofenac potassium and its process related impurities in solid oral dosage form, J. Chromatogr. Sep. Tech. 9 (2018) 1–15. DOI:10.4172/2157-7064.1000412 Search in Google Scholar

13 Sarhangzadeh, K., Khatami, A. A., Jabbari, M. and Bahari, S.: Simultaneous determination of diclofenac and indomethacin using a sensitive electrochemical sensor based on multiwalled carbon nanotube and ionic liquid nanocomposite, J. Appl. Electrochem. 43 (2013) 1217–1224. DOI:10.1007/s10800-013-0609-3 Search in Google Scholar

14 Demircan, S., Sayin, F., Basci, N. E., Kir, S. and Kocaoglan, H.: Determination of diclofenac in subretinal and aqueous humor fluids by HPLC with electrochemical detector, FABAD J. Pharm. Sci. 30, (2005) 33–39. Search in Google Scholar

15 Chethana, B. K., Basavanna, S. and Naik, Y. A.: Voltammetric determination of diclofenac sodium using tyrosine-modified carbon paste electrode, Ind. Eng. Chem. Res. 51 (2012) 10287–10295 DOI:10.1021/ie202921e Search in Google Scholar

16 Hassan, S. S. M., Mahmoud, W. H., Elmosallamy, M. A. F. and Almarzooqi, M. H.: Determination of diclofenac in pharmaceutical preparations using a novel PVC membrane sensor, Pharmazie 58 (2003) 29–31. Search in Google Scholar

17 Pandya, E. J., Kapupara P. and Shah, K. V.: Development and validation of simultaneous estimation of diclofenac potassium, paracetamol and serratiopeptidase by first order derivative UV spectroscopy method in pharmaceutical formulation, J. Chem. Pharm. Res. 6 (2014) 912–924. Search in Google Scholar

18 Paton-Morales, P. and Talens-Alesson, F. I.: Effect of ionic strength and competitive adsorption of Na+ on the flocculation of lauryl sulfate micelles with Al3+, Langmuir, 17 (2001) 6059–6064 DOI:10.1021/la0103362 Search in Google Scholar

19 Valente, A. J. M., Burrows, H. D., Pereira, R. F., Ribeiro, A. C. F., Pereira, J. L. G. C. and Lobo, V. M. M.: Effect of europium(III) chloride on the aggregation behavior of sodium dodecyl sulfate, Langmuir, 22 (2006) 5625–5629. PMid:16768486; DOI:10.1021/la060285e Search in Google Scholar

20 Neves, A. C. S., Valente, A. J. M., Burrows, H. D., Ribeiro, A. C. F. and Lobo, V. M. M.: Effect of terbium(III) chloride on the micellization properties of sodium decyl- and dodecyl-sulfate solutions, J. Colloid. Interface. Sci. 306 (2007) 166–174. PMid:17107684; DOI:10.1016/j.jcis.2006.10.061 Search in Google Scholar

21 Hinze, W. L., Singh, H. N., Baba, Y. and Harvey, N. G.: Micellar enhanced analytical fluorimetry; Trends. Anal. Chem. 3 (1984) 193–199. DOI:10.1016/0165-9936(84)85006-2 Search in Google Scholar

22 Mclntire, G. L. and Dorsey, J. G.: Micelles in analytical chemistry; Crit. Rev. Anal. Chem. 21 (1990) 257–278. DOI:10.1080/10408349008051631 Search in Google Scholar

23 Sbai, M., Ait-Lyazidi, S., Lerner, D. A., del-Castillo, B. and Martin, M. A.: Use of micellar media for the fluorimetric determination of ellipticine in aqueous solutions; J. Pharm. Biomed. Anal. 14 (1996) 959–965. DOI:10.1016/S0731-7085(96)01759-1 Search in Google Scholar

24 Shah, J., Jan, M. R., Khan, M. N. and Inayatullah: Development and validation of micellar-enhanced spectrofluorimetric method for determination of sulpiride in pharmaceutical formulations and biological samples; Tensid. Surf. Det. 49 (2012) 451–457. DOI:10.3139/113.110216 Search in Google Scholar

25 Sabry, S. M.: Determination of flufenamic acid and mefenamic acids in pharmaceutical preparations using organized media; Anal. Chim. Acta. 367 (1998) 41–53. DOI:10.1016/s0003-2670(98)00172-x Search in Google Scholar

26 Khan, M. N., Bibi, N., Irum and Idrees, M.: A micellar-enhanced spectrofluorimetric method for the determination of ciprofloxacin in pure form, pharmaceutical preparations and biological samples, Tensid. Surf. Det. 56 (2019) 510–515. DOI:10.3139/113.110646 Search in Google Scholar

27 Vılchez, J. L., Taoufiki, J., Ballesteros, O. and Navalon, A.: Micelle-enhanced spectrofluorimetric method for the determination of antibacterial trovafloxacin in human urine and serum, Microchim. Acta, 150, (2005), 247–252. DOI:10.1007/s00604-005-0369-9 Search in Google Scholar

28 Atia, N. N., Mahmoud, A. M., El-Shabouri, S, R. and El-Koussi, W. M.: Two validated spectrofluorimetric methods for determination of gemifloxacin mesylate in tablets and human plasma, Int. J. Anal. Chem., (2013), 1–11. PMid:23762060; DOI:10.1155/2013/137279 Search in Google Scholar

29 de Souza, R. L. and Tubino, M.: Spectrophotometric determination of diclofenac in pharmaceutical preparations, J. Braz. Chem. Soc. 16 (2005) 1068–1073. DOI:10.1590/S0103-50532005000600026 Search in Google Scholar

30 Abdelrahman, M. M., Abdelwahab, N. S., Taha, A. A. and Boshra, J. M.: Determination of chlorzoxazone, diclofenac potassium, and chlorzoxazone toxic degradation product by different chromatographic methods, J. Planar Chromatography, 29 (2016),453–461. DOI:10.1556/1006.2016.29.6.8 Search in Google Scholar

31 Panda, S., Patanaik, D. and Ravi Kumar, B. V. V.: New stability-indicating RPHPLC method for determination of diclofenac potassium and metaxalone from their combined dosage form, Sci. Pharm. 80 (2012) 127–137. PMid:22396909; DOI:10.3797/scipharm.1109-16 Search in Google Scholar

Received: 2020-07-05
Accepted: 2021-06-16
Published Online: 2021-11-30

© 2021 Walter de Gruyter GmbH, Berlin/Boston, Germany