Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies

Czasopismo : Acta Chromatographica
Tytuł artykułu : Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence 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,
El-Shaboury, S. R.
Assiut University Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy Assiut 71526 Egypt,
Hussein, A. S.
Assiut University Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy Assiut 71526 Egypt,
Mohamed, N. A.
Assiut University Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy Assiut 71526 Egypt, mohamed_mounir2000@yahoo.com,
El-Sutohy, M. M.
Al-Azhar University, Assiut Branch Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy Assiut 71524 Egypt,
Madej, K.
Jagiellonian University Department of Analytical Chemistry, Faculty of Chemistry Ingardena St. 3 30-060 Krakow Poland, madejk@chemia.uj.edu.pl,
Persona, K.
Jagiellonian University Department of Analytical Chemistry, Faculty of Chemistry Ingardena St. 3 30-060 Krakow Poland,
Nizio, M.
Jagiellonian University Department of Analytical Chemistry, Faculty of Chemistry Ingardena St. 3 30-060 Krakow Poland,
Emami, J.
Isfahan University of Medical Sciences Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences Isfahan Iran, emami@pharm.mui.ac.ir,
Rezazadeh, M.
Isfahan University of Medical Sciences Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences Isfahan Iran,
Abstrakty : A simple, rapid, and sensitive reversed-phase HPLC method was developed and validated for determination of metronidazole and tinidazole in human plasma samples under identical chromatographic conditions. This method involves liquid-liquid extraction using chloroform: isopropylalcohol (95:5). Chromatographic separation was performed using a μ-bondapack C18 (250 mm × 4.6 mm) column. The mobile phase consisted of potassium dihydrogen phosphate solution (0.005 M)/acetonitrile (80/20 v/v). The final pH of the mobile phase was adjusted to 4 ± 0.1 with orthophosphoric acid. The calibration curves were linear over the concentration range 0.1–15 μg/mL for metronidazole and tinidazole with the detection limit of 30 ng/mL. Within- and between-day precision and accuracy did not exceed 9.83% and 10.48%, respectively. Metronidazole and tinidazole were found to be stable in plasma samples with no evidence of degradation during 3 freeze-thaw cycles and 3 months storage in −70 °C. The current validated bio-analytical method was finally applied in bioequivalence studies of two different metronidazole and tinidazole products according to a standard two-way cross-over design with a two-week washout period. No statistically significant difference was observed between the logarithmically transformed AUC0-∞ and Cmax values. Therefore, generic products were considered bioequivalent with those of standards which could be used interchangeably.

Słowa kluczowe : metronidazole, tinidazole, HPLC, pharmacokinetics, bioavailability,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2013
Numer : Vol. 25, no. 1
Strony : 111 – 125
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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. ,El-Shaboury, S. R. ,Hussein, A. S. ,Mohamed, N. A. ,El-Sutohy, M. M. ,Madej, K. ,Persona, K. ,Nizio, M. ,Emami, J. ,Rezazadeh, M. , Rapid, sensitive, and validated HPLC method for analysis of metronidazole and tinidazole under identical chromatographic conditions with UV detection and liquid-liquid extraction: application in bioequivalence studies. Acta Chromatographica Vol. 25, no. 1/2013
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