Sensitive and Selective Extractive Spectrophotometric Method for the Determination of Hydroxyzine Dihydrochloride in Pharmaceuticals


  • Nagaraju Rajendraprasad University of Mysore
  • Kanakapura Basavaiah University of Mysore
  • Kanakapura Basavaiah Vinay University of Mysore
  • Hosakere Doddarevanna Revanasiddappa University of Mysore



Spectrophotometry; hydroxyzine; orange II; pharmaceuticals.


Hydroxyzine dihydrochloride (HDH), a piperazine H1-receptor antagonist and antihistamine, is a rapid acting anxiolytic used principally as an anti-emetic. 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 x 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 co-formulated substances.

Recoveries were 96-109 %.


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Author Biographies

Nagaraju Rajendraprasad, University of Mysore

Department of Studies in Chemistry

Kanakapura Basavaiah, University of Mysore

Department of Studies in Chemistry

Kanakapura Basavaiah Vinay, University of Mysore

Department of Studies in Chemistry

Hosakere Doddarevanna Revanasiddappa, University of Mysore

Department of Studies in Chemistry


1. Ferreri, M.; Hantouche, E. G. Acta Psychiatrica Scandinavica Supplementum. 1998, 393, 102-108.
2. Reynolds, J. E. F. Martindale. The Extra Pharmacopoeia, 30th ed.; The Pharmaceutical Press, London, 1993.
3. Capella-Peiro, M. E.; Bossi, A.; Esteve, R. J. Anal. Biochem. 2006, 352, 41-49.
4. Roberts, S. E.; Delaney, M. F. J. Chromatogr. A 1982, 242, 364-368.
5. Menon, G. N.; Norris, B. J. J. Pharm. Sci. 1981, 70, 697-698.
6. Papas, A. N.; Marchese, S. M.; Delaney, M. F. LC, Liq. Chromatogr. HPLC Mag. 1984, 2, 120–121.
7. Boberic-Borojevic, D.; Radulovic, D.; Ivanovic, D.; Ristic, P. J. Pharm. Biomed. Anal. 1999, 21, 15-22.
8. Pehoursq, F. J. Pharm. Tox. Meth. 2004, 50, 41-44.
9. Kintz, P.; Godelar, B.; Mangin, P. Forensic. Sci. Int, 1990, 48, 139-143.
10. Ackermann, H.; Kretzschmann, F.; Kruger, S.; Lexow, B. Nahrung-Food 1977, 21, 603-610.
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.
12. Beltagi, A. M.; Abdallah, O. M.; Ghoneim, M. M. Talanta 2008, 74, 851-859
13. Neng, Z.; Liang, Y.-Z.; Chen, B.-M.; Ping, W.; Xian, C.; Liu, F.-P. Chromatographia 2007, 66, 481-486.
14. Bouklouze, A.; Elbouzekraoui, M.; Cherrah, Y.; Hassar, M.; Kauffmann, J. M.; Electroanalysis 2002, 14, 1369-1374.
15. Ciaccio, L. L.; Missan, S. R.; McMullen, W. H.; Grenfeel, T. C. Anal. Chem, 1957, 29, 1670–1673.
16. Pasich, J.; Stasiewska, K. Acta. Pol. Pharm, 1962, 19, 181–182.
17. Basavaiah, K.; Charan, V. S. Acta Cienc. Indica Ser. Chem. 2001, 27, 91-96.
18. Basavaiah, K.; Charan, V.S. Il Farmaco 2002, 57, 9–17.
19. Basavaiah, K.; Charan, V.S.; Chandrashekar V. Ind. J. Pharm. Sci, 2002, 64, 251-253.
20. Sanrick, B.; Janik, B. Acta. Pol. Pharm, 1966, 23, 573–575.
21. Dembinski, B. Chem. Anal. (Warsaw), 1993, 38, 183–187.
22. Rajendraprasad, N.; Basavaiah, K.; Vinay, K. B. Chem. Ind. Chem. Eng. Quart, 2010, 16, 127-132.
23. The US Pharmacopeia (USP 28); The National Formulary (NF 23).; US Pharmacopeial Convention Inc, 2005, p.982.
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.
25. Kurzawa, M.; Dembinski, B.; Szydlowska-Czerniak, A. Acta. Pol. Pharma. 1999, 56, 255-260.
26. Basavaiah, K.; Charan, V. S. Ind. J. Pharm Sci. 2003, 65, 660-662.
27. Sane, R. T.; Surve, V.; Francis, M. Indian Drugs 2000, 8, 390-393.
28. Gowda, B. G.; Melwanki, M. B.; Seetharamappa J. J. Pharm. Biomed. Anal. 2001, 25, 1021-1026.
29. Ramappa, P. G.; Revanasiddappa, H. D. Indian Drugs 2001, 38, 97-99.
30. Mostafa, S.; El-Sadek, M.; Alla, E. A. J. Pharm. Biomed. Anal. 2002, 28, 173-180.
31. Reddy, M. N.; Murthy, T. K.; Rao, Y. S.; Sushma, K.; Sankar, D . G. Indian Drugs 2002, 39, 106-109.
32. Skoog, D. A.; West, D. M. Principles of Instrumental Analysis, 2nd ed., Holt, Rinhart and Winston, New York, 1971, p. 104.
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.
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.
35. Inczedy, J.; Lengyel, T.; Ure, A. M.; Gelencser, A.; Hulanicki, A. IUPAC Compendium of Analytical Nomenclature: Definitive Rules, Blackwell Science Inc., Boston, 1998.





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