Development and validation of a stability-indicating HPLC method for analysis of celecoxib (CXB) in bulk drug and microemulsion formulations

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and validation of a stability-indicating HPLC method for analysis of celecoxib (CXB) in bulk drug and microemulsion formulations

Autorzy :
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,
Abstrakty : A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of celecoxib (CXB), a selective COX-2 inhibitor, both in bulk drug and in microemulsions. Reversed-phase chromatography was performed on a C18 column with methanol–water, 75:25 (%, v/v), as mobile phase at a flow rate of 1.25 mL min-1. Detection was performed at 250 nm and a sharp peak was obtained for CXB at a retention time of 4.8 ± 0.01 min. Linear regression analysis data for the calibration plot showed there was a good linear relationship between response and concentration in the range 0.27–80 µg mL-1; the regression coefficient was 0.996 and the linear regression equation was y = 48415x + 54359. The detection (LOD) and quantification (LOQ) limits were 0.086 and 0.2625 µg mL-1 respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of CXB. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of CXB with high precision and accuracy.

Słowa kluczowe :
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2007
Numer : No. 18
Strony : 116 – 129
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Cytuj : Bartnik, M. ,Kowalski, R. ,Polak, B. ,Turło, J. ,Szyrwińska, K. ,Czauderna, M. ,Bączek, T. ,Chilmonczyk, Z. ,Hung, Ch. Y. ,Baboota, S. , Development and validation of a stability-indicating HPLC method for analysis of celecoxib (CXB) in bulk drug and microemulsion formulations. Acta Chromatographica No. 18/2007