Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Czasopismo : Acta Chromatographica
Tytuł artykułu : Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Autorzy :
Petruczynik, A.
Medical University of Lublin Department of Inorganic Chemistry 4a Chodźki Str. 20-093 Lublin Poland, annapetruczynik@poczta.onet.pl,
Waksmundzka-Hajnos, M.
Medical University of Lublin Department of Inorganic Chemistry 4a Chodźki Str. 20-093 Lublin Poland,
Rykowska, I.
Adam Mickiewicz University Faculty of Chemistry Umultowska 89b 61-614 Poznań Poland, obstiwo@amu.edu.pl,
Wasiak, W.
Adam Mickiewicz University Faculty of Chemistry Umultowska 89b 61-614 Poznań Poland,
Inglot, T. W.
Medical University of Lublin Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Gumieniczek, A.
anna.gumieniczek@am.lublin.pl,
Komsta, Ł.
Medical University of Lublin Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Związek, R.
Medical University of Lublin Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Sharaf El Din, M. K.
Mansoura University Department of Analytical Chemistry, Faculty of Pharmacy Mansoura 35516 Egypt,
Ibrahim, F.
Mansoura University Department of Analytical Chemistry, Faculty of Pharmacy Mansoura 35516 Egypt,
Eid, M. I.
Mansoura University Department of Analytical Chemistry, Faculty of Pharmacy Mansoura 35516 Egypt,
Wahba, M. E. K.
Mansoura University Department of Analytical Chemistry, Faculty of Pharmacy Mansoura 35516 Egypt, marywahba2004@yahoo.com,
Abstrakty : An accurate, simple, sensitive, and selective micellar liquid chromatographic method has been developed for the simultaneous determination of cetirizine dihydrochloride in two of its combined pharmaceutical preparations with psudoephedrine hydrochloride and/or paracetamol. The chemometrics approach was applied for the optimization of separation of the studied drugs to optimize their separation; the effect of six experimental parameters on retention was investigated by means of multivariate analysis. Separation was conducted using an ODS C18 (150 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 250 nm. A mobile phase composed of 0.135 M sodium dodecyl sulphate, 11% 1-propanol, 0.3% tri-ethylamine in 0.02 M phosphoric acid, and adjusted to pH 3.3 has been used at a flow rate of 1 mL/min. Regression models were characterized by both descriptive and predictive ability (R2 ≥ 98.8% and R2cv ≥ 94.5%) and allowed the chromatographic separation of the drugs with a good resolution and a total analysis time within 6 min.The calibration curves were rectilinear over the concentration ranges of 0.05–1.0, 0.07–4.0, and 1.0–10.0 μg/mL for cetirizine dihydrochloride, psudoephedrine hydrochloride, and paracetamol respectively; with detection limits of 0.01, 0.05, and 0.08 μg/mL, and quantification limits of 0.04, 0.09, and 1.02 μg/mL, respectively. The results obtained were in good agreement with those obtained by the comparison method. Furthermore, the method was applied for the determination of the drugs in spiked human plasma and used to reveal the pharmacokinetic characters in a healthy volunteer treated with oral administration of the studied two combined dosage forms of cetirizine.

Słowa kluczowe : micellar liquid chromatography, chemometric optimization, cetirizine, psudoephedrine, paracetamol, pharmacokinetics,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2013
Numer : Vol. 25, no. 1
Strony : 59 – 77
Bibliografia : 1 H. Okamoto, T. Nakajima, Y. Ito, T. Aketo, K. Shimada, S. Yamato, J. Pharm. Biomed. Anal., 37, 517 (2005)
2 The British Pharmacopoeia. The Stationary Office, London 2008
3 S. Sweetman (Ed.) “Martindale: The complete drug reference” Pharmaceutical press. Electronic version: London, 2006
4 B.S. Nagaralli, J. Seetharamappa, B.G. Gowda, M.B. Melwanki, J. Chromatogr. B, 798, 49 (2003)
5 G.V. Kanumula, B. Raman, M. Sunderesan, Indian Drugs, 38, 294 (2001)
6 Q.F. Liao, Z.Y. Xie, B.Y. Pan, C.C. Zhu, M.C. Yao, X.J. Xu, J.Z. Wan, Chromatographia, 67, 687 (2008)
7 M.L. Qi, P. Wang, L. Zhou, J.L. Gu, R.N. Fu, Chromatographia, 57, 139 (2003)
8 M.L. Qi, P. Wang, L. Zhou, Y. Sun, Chromatographia, 58, 183 (2003)
9 K. Nerurkar, U.J. Dhorda, I.C. Bhoir, M. Sundaresan, Indian Drugs, 39, 410 (2002)
10 S. Karakus, I. Kucukguzel, S.G. Kucukguzel, J. Pharm. Biomed. Anal., 46, 295 (2008)
11 M. Ma, F. Feng, Y.L. Sheng, S.J. Cui, H. Liu, J. Chromatogr. B, 846, 105 (2007)
12 Z.R. Tan, D.S. Ouyang, G. Zhou, L.S. Wang, Z. Li, D. Wang, H.H. Zhou, J. Pharm. Biomed. Anal., 42, 207 (2006)
13 G. M. Hadada, S. Emarab, W.M.M. Mahmouda, Talanta, 79, 1360 (2009)
14 M.D. Rukhadze, V. Rmeyer, J. Chromatogr. A, 805, 45 (1998)
15 M.G. Gennaro, D. Giacosa, J. Liq. Chromatogr., 17, 4365 (1994)
16 E. Marengo, M.C. Gennaro, Anal. Chim. Acta, 321, 225 (1996)
17 A.K. Smilde, A. Knevelman, J. Chromatogr., 369, 1 (1986)
18 E. Marengo, M.C. Gennaro, J. Chromatogr. A, 863, 1 (1999)
19 United States Pharmacopeial Convention: United States Pharmacopoeia 30; National Formulary 25. US Pharmacopoeia Convention: Rockville, MD; 2007
20 Guidance for industry; Q2B of analytical procedure: Methodology; International Conference on Hormonization (ICH), November 2005. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073384.pdf
21 J.C. Miller, J-N. Miller, Statistics for Analytical Chemistry, Wiley; New York. p. 256, 2005
22 O. Yin, B. Tomlinson, A.H.L. Chow, M.S.S. Chow, Inter. Journal of Pharm., 222, 305 (2001)
DOI :
Cytuj : Petruczynik, A. ,Waksmundzka-Hajnos, M. ,Rykowska, I. ,Wasiak, W. ,Inglot, T. W. ,Gumieniczek, A. ,Komsta, Ł. ,Związek, R. ,Sharaf El Din, M. K. ,Ibrahim, F. ,Eid, M. I. ,Wahba, M. E. K. , Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies. Acta Chromatographica Vol. 25, no. 1/2013
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