Development and validation of a stability-indicating RP-HPLC method for analysis of doxofylline in human serum. Application of the method to a pharmacokinetic study

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and validation of a stability-indicating RP-HPLC method for analysis of doxofylline in human serum. Application of the method to a pharmacokinetic study

Autorzy :
Sherma, J.
Department of Chemistry, Lafayette College, Easton, PA 18042, USA,
Vrchotová, N.
Institute of Systems Biology and Ecology AS CR, Branišovská 31, 370 05 České Budějovice, Czech Republic,
Sivakumar, T.
Department of Pharmacy, Faculty of Engineering and Technology, Annamalai University, Annamalainagar, Tamil Nadu-608 002, India,
Petruczynik, A.
Department of Inorganic Chemistry, Medical University, Staszica 6, 20-081 Lublin, Poland,
Benkő, B.
PhD School of Semmelweis University, 1085 Budapest, Üllői út 26, Hungary, Division of Pharmacology and Drug Safety, Richter Gedeon Rt., Gyömrői út 21, 1475 Budapest, P.O. Box 27, Hungary, Department of Chemistry and Biochemistry, University of Pécs, Péc,
Mori, M.
Department of Chemistry, Faculty of Engineering, Gunma University, 1-5-1 Tenjin-cho, Kiryu, 376-8515, Japan,
Solangi, A. R.
National Center of Excellence in Analytical Chemistry, University of Sindh, Jamshoro, Pakistan,
Idris, A. M.
Department of Chemistry, College of Science, King Faisal University, Hofuf 31982, Saudi Arabia,
Milán-Segovia, R.
Laboratorio de Farmacia, Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, Ave. Manuel Nava No. 6, 78290 San Luis Potosí, S.L.P., Mexico,
Qutab, S. S.
Schazoo Laboratories (Pvt) Ltd, 45 G.T. Road, Lahore-54000, Pakistan,
Agil, M.
Faculty of Pharmacy, Hamdard University New Delhi, 110 062, India,
Dhaneshwar, S. S.
Department of Pharmaceutical Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Erandwane, Pune-411 038, India,
Gannu, R.
Centre for Biopharmaceutics and Pharmacokinetics, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Andhra Pradesh, India,
Abstrakty : A simple, isocratic, stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for determination of doxofylline in human serum. The method employs precipitation for isolation and sample concentration, followed by reversed-phase liquid chromatographic analysis with ultraviolet (UV) detection at 275 nm. Analytes were extracted from serum with 400 µL methanol. Samples containing the internal standard (metronidazole) and doxofylline were chromatographed on a C18 column with 18:82 acetonitrile–phosphate buffer (12.5 mM potassium dihydrogen orthophosphate, pH 3.0) as mobile phase at a flow rate of 1 mL min.1. The retention times of doxofylline and metronidazole were 7.54 min and 4.36 min, respectively. The intra-day and inter-day coefficients of variation and the error of the assay were <15%. The calibration plot was linear for concentrations in the range of 0.025 to 25 µg mL.1. The extraction recovery of doxofylline was >95%. The validated method was applied to a pharmacokinetic study of doxofylline in human serum after administration of a single doxofylline tablet (400 mg). The method is ideally suited to estimation of the drug for pharmacokinetic studies on human volunteers after oral administration of doxofylline.

Słowa kluczowe :
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2007
Numer : No. 19
Strony : 149 – 160
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Cytuj : Sherma, J. ,Vrchotová, N. ,Sivakumar, T. ,Petruczynik, A. ,Benkő, B. ,Mori, M. ,Solangi, A. R. ,Idris, A. M. ,Milán-Segovia, R. ,Qutab, S. S. ,Agil, M. ,Dhaneshwar, S. S. ,Gannu, R. , Development and validation of a stability-indicating RP-HPLC method for analysis of doxofylline in human serum. Application of the method to a pharmacokinetic study. Acta Chromatographica No. 19/2007