Journal : Acta Chromatographica
Article : Development and validation of a reversed-phase HPLC method for simultaneous determination of domperidone and pantoprazole in pharmaceutical dosage forms

Authors :
Bartnik, M.
Department of Pharmacognosy with Medicinal Plant Laboratory, Medical University, 1, Chodźki Str., 20-093 Lublin, Poland,
Kowalski, R.
Subdepartment of Food Quality Assessment and Central Apparatus Laboratory, Agricultural University, 20-950 Lublin, Akademicka 13, Poland,
Polak, B.
Department of Physical Chemistry, Faculty of Pharmacy, Medical University, Lublin, Poland,
Turło, J.
Department of Drug Technology, Medical University of Warsaw, 1, Banacha Street, 02-097 Warsaw, Poland,
Szyrwińska, K.
Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Poznań University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland,
Czauderna, M.
The Kielanowski Institute of Animal Physiology and Nutrition, Polish Academy of Sciences, 05-110 Jabłonna, Poland,
Bączek, T.
Medical University of Gdańsk, Department of Biopharmaceutics and Pharmacodynamics, Gdańsk, Poland,
Chilmonczyk, Z.
National Medicines Institute, 30/34, Chełmska Str., 00-725 Warsaw, Poland,
Hung, Ch. Y.
Department of Biotechnology, National Formosa University, Huwei, Yunlin, 632, Taiwan,
Baboota, S.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062, India,
Sivakumar, T.
Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu-608 002, India,
Abstract : A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of domperidone and pantoprazole in capsules. The compounds were separated on an ODS analytical column with a mixture of methanol, acetonitrile, and triethylamine solution (10 mM, pH 7.0 ± 0.05 adjusted with 85% phosphoric acid) in the ratio 20:33:47 (v/v) as mobile phase at a flow rate of 1.0 mL min-1. UV detection was performed at 285 nm. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The developed and validated method was successfully used for quantitative analysis of Pantop-D capsules. Total chromatographic analysis time per sample was approximately 10 min with pantoprazole, acetophenone (internal standard), and domperidone eluting with retention times of 4.34, 5.52, and 9.46 min, respectively. Validation studies revealed the method is specific, rapid, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0.5–5 µg mL-1 and 1–10 žg mL-1 for domperidone and pantoprazole, respectively. The LODs were 15.3 and 3.0 ng mL-1 and the LOQs were 51.0 and 10.1 ng mL-1 for domperidone and pantoprazole, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for determination of domperidone and pantoprazole in capsules.

Keywords :
Publishing house : University of Silesia in Katowice
Publication date : 2007
Number : No. 18
Page : 130 – 142

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Qute : Bartnik, M. ,Kowalski, R. ,Polak, B. ,Turło, J. ,Szyrwińska, K. ,Czauderna, M. ,Bączek, T. ,Chilmonczyk, Z. ,Hung, Ch. Y. ,Baboota, S. ,Sivakumar, T. ,Sivakumar, T. , Development and validation of a reversed-phase HPLC method for simultaneous determination of domperidone and pantoprazole in pharmaceutical dosage forms. Acta Chromatographica No. 18/2007