Sensitive and Selective Extractive Spectrophotometric Method for the Determination of Hydroxyzine Dihydrochloride in Pharmaceuticals
Nagaraju Rajendraprasad, Kanakapura Basavaiah,* Kanakapura Basavaiah Vinay and Hosakere Doddarevanna Revanasiddappa
Department of Studies in Chemistry, Manasagangothri, University of Mysore, Mysore 570 006, India. e–mail: basavaiahk@yahoo.co.in
Received June 17, 2010.
Accepted September 10, 2010.
Abstract
Hydroxyzine dihydrochloride (HDH), a piperazine H1–receptor antagonist and antihistamine, is a rapid acting anxiolytic used principally as an antiemetic. A sensitive, selective, and precise and accurate spectrophotometric method based on the formation of an ion–pair with orange II (ORG II) as ion–pair complexing agent was developed and validated for the determination of HDH in pharmaceuticals. The chloroform–extractable ion–pair complex exhibited an absorption maximum at 480 nm. Optimization of different experimental conditions is described. Beer's law is obeyed in the range of 1.5–15 μg mL–1 with an apparent molar absorptivity value of 2.07 × 104 L mol–1 cm–1 and Sandell's sensitivity value of 0.0216 μg cm–2. The limit of detection (LOD) and limit of quantification (LOQ) are 0.14 and 0.41 μg mL–1, respectively. A Job's plot of absorbance versus molar ratio of HDH to ORG II indicated (1:2) stoichiometric ratio. Within–and between–day relative standard deviations at three different concentration levels were < 3%. The developed method was successfully applied to commercial tablets. The results obtained were in good agreement with those obtained using the official method. No interference was encountered from coformulated substances. Recoveries were 96–109 %.
Keywords: Spectrophotometry, hydroxyzine, orange II, pharmaceuticals.
Resumen
El dihidrocloruro de hidroxicina (HDH), una piperazina antagonista del receptor H1 y un antihistamínico, es un ansiolítico de acción rápida usado principalmente como anti–emético. Se desarrolló y validó un método espectrofotométrico sensible, selectivo, preciso y exacto basado en la formación de un par iónico con naranja II (ORG II) como un agente complejante para la determinación de HDH en productos farmacéuticos. El par iónico extraído en cloroformo exhibió un máximo de absorción a 480 nm. Se describió la optimización de las diferentes condiciones experimentales. La ley de Beer se obedeció en el intervalo de 1.5–15 μg mL–1 con un valor de absortividad molar aparente de 2.07 × 104 L mol–1 cm–1 y un valor de sensibilidad de Sandell de 0.0216 μg cm–2. El límite de detección (LD) y el límite de cuantificación (LC) son 0.14 y 0.41 μg mL–1, respectivamente. Una gráfica de Job de absorbancia versus relación molar de HDH y ORG II indicó una relación estequiométrica (1:2). Las desviaciones estándar relativas dentro y entre días, a tres diferentes niveles de concentración, fueron < 3%. El método desarrollado fue aplicado exitosamente a tabletas comerciales. Los resultados obtenidos estuvieron en buena concordancia con los obtenidos con el método oficial. No se encontró ninguna interferencia de parte de las sustancias de la formulación. Las recuperaciones fueron de 96–109 %.
Palabras clave: Espectrofotometría, hidroxicina, naranja II, productos farmacéuticos.
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1. Ferreri, M.; Hantouche, E. G. Acta Psychiatrica Scandinavica Supplementum. 1998, 393, 102–108. [ Links ]
2. Reynolds, J. E. F. Martindale. The Extra Pharmacopoeia, 30th ed.; The Pharmaceutical Press, London, 1993. [ Links ]
3. Capella–Peiro, M. E.; Bossi, A.; Esteve, R. J. Anal. Biochem. 2006, 352, 41–49. [ Links ]
4. Roberts, S. E.; Delaney, M. F. J. Chromatogr. A 1982, 242, 364368. [ Links ]
]]>5. Menon, G. N.; Norris, B. J. J. Pharm. Sci. 1981, 70, 697–698. [ Links ]
6. Papas, A. N.; Marchese, S. M.; Delaney, M. F. LC, Liq. Chromatogr. HPLC Mag. 1984, 2, 120–121. [ Links ]
7. Boberic–Borojevic, D.; Radulovic, D.; Ivanovic, D.; Ristic, P. J. Pharm. Biomed. Anal. 1999, 21, 15–22. [ Links ]
8. Pehoursq, F. J. Pharm. Tox. Meth. 2004, 50, 41–44. [ Links ]
9. Kintz, P.; Godelar, B.; Mangin, P. Forensic. Sci. Int, 1990, 48, 139–143. [ Links ]
]]>10. Ackermann, H.; Kretzschmann, F.; Kruger, S.; Lexow, B. Nahrung–Food 1977, 21, 603–610. [ Links ]
11. Martinez–Algaba, C.; Bermudez–Saldana, J. M.; Villanueva–Camanas, R. M.; Sagrado, S.; Medina–Hernandez, M. J. J. Pharm. Biomed. Anal. 2006, 40, 312–321. [ Links ]
12. Beltagi, A. M.; Abdallah, O. M.; Ghoneim, M. M. Talanta 2008, 74, 851–859 [ Links ]
13. Neng, Z.; Liang, Y.–Z.; Chen, B.–M.; Ping, W.; Xian, C.; Liu, F.–P. Chromatographia 2007, 66, 481–486. [ Links ]
14. Bouklouze, A.; Elbouzekraoui, M.; Cherrah, Y.; Hassar, M.; Kauffmann, J. M.; Electroanalysis 2002, 14, 1369–1374. [ Links ]
15. Ciaccio, L. L.; Missan, S. R.; McMullen, W. H.; Grenfeel, T. C. Anal. Chem, 1957, 29, 1670–1673. [ Links ]
16. Pasich, J.; Stasiewska, K. Acta. Pol. Pharm, 1962, 19, 181–182. [ Links ]
17. Basavaiah, K.; Charan, V. S. Acta Cienc. Indica Ser. Chem. 2001, 27, 91–96. [ Links ]
18. Basavaiah, K.; Charan, V.S. IlFarmaco 2002, 57, 9–17. [ Links ]
19. Basavaiah, K.; Charan, V.S.; Chandrashekar V. Ind. J. Pharm. Sci, 2002, 64, 251–253. [ Links ]
20. Sanrick, B.; Janik, B. Acta. Pol. Pharm, 1966, 23, 573–575. [ Links ]
21. Dembinski, B. Chem. Anal. (Warsaw), 1993, 38, 183–187. [ Links ]
22. Rajendraprasad, N.; Basavaiah, K.; Vinay, K. B. Chem. Ind. Chem. Eng. Quart, 2010, 16, 127–132. [ Links ]
23. The US Pharmacopeia (USP 28); The National Formulary (NF 23).; US Pharmacopeial Convention Inc, 2005, p.982. [ Links ]
24. Sane, R. T.; Vaidya, U. M.; Nayak, V. G.; Dhamankar, A. Y.; Joshi, S. K.; Doshi, V. J.; Sawant, S. V.; Malkar, V. B.; Pandit, V. R.; Sathe, A. Y.; Jukar, S.; Nadakarni A. D. Indian Drugs 1982, 19, 398–403. [ Links ]
25. Kurzawa, M.; Dembinski, B.; Szydlowska–Czerniak, A. Acta. Pol. Pharma. 1999, 56, 255–260. [ Links ]
26. Basavaiah, K.; Charan, V. S. Ind. J. Pharm Sci. 2003, 65, 660662. [ Links ]
27. Sane, R. T.; Surve, V.; Francis, M. Indian Drugs 2000, 8, 390393. [ Links ]
28. Gowda, B. G.; Melwanki, M. B.; Seetharamappa J. J. Pharm. Biomed. Anal. 2001, 25, 1021–1026. [ Links ]
29. Ramappa, P. G.; Revanasiddappa, H. D. Indian Drugs 2001, 38, 97–99. [ Links ]
30. Mostafa, S.; El–Sadek, M.; Alla, E. A. J. Pharm. Biomed. Anal. 2002, 28, 173–180. [ Links ]
31. Reddy, M. N.; Murthy, T. K.; Rao, Y. S.; Sushma, K.; Sankar, D. G. Indian Drugs 2002, 39, 106–109. [ Links ]
32. Skoog, D. A.; West, D. M. Principles of Instrumental Analysis, 2nd ed., Holt, Rinhart and Winston, New York, 1971, p. 104. [ Links ]
33. Zavis, H.; Ludvik, D.; Milan, K.; Ladislaw, S.; Frantisck, V. Handbook of Organic Reagents in Inorganic Analysis. John Wiley & Sons, New York, 1976, p. 364. [ Links ]
34. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London. [ Links ]
35. Inczedy, J.; Lengyel, T.; Ure, A. M.; Gelencser, A.; Hulanicki, A. IUPAC Compendium of Analytical Nomenclature: Definitive Rules, Blackwell Science Inc., Boston, 1998. [ Links ]
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