Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs

Czasopismo : Acta Chromatographica
Tytuł artykułu : Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs

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,
Sivakumar, T.
Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu-608 002, India,
Ivanović, D.
Faculty of Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, 11000 Belgrade, Serbia,
Pavlova, V.
Institute of Chemistry, Faculty of Natural Sciences and Mathematics, Saints Cyril and Methodius University, Arhimedova 5, P.O. Box 162, 1000 Skopje, Macedonia,
Ali, J.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110062, India,
Abstrakty : A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been established and validated for analysis of isoniazid and rifampicin both as the bulk drugs and in formulations. The compounds were separated on aluminumbacked silica gel 60 F254 plates with n-hexane–2-propanol–acetone–ammonia–formic acid, 3:3.8:2.8:0.3:0.1 (v/v) as mobile phase. This system was found to give compact spots for isoniazid and rifampicin (RF values 0.59 ± 0.02 and 0.73 ± 0.04, respectively). Densitometric analysis of isoniazid and rifampicin was performed at 254 nm. Regression analysis data for the calibration plots were indicative of good linear relationships between response and concentration over the range 100–700 ng per spot. The correlation coefficients, r2, were 0.994 and 0.997 for isoniazid and rifampicin respectively. The values of slope and intercept of the calibration plots were 3.755 ± 0.22 and 3099.1 ± 51.21, respectively, for isoniazid and 4.0957 ± 0.25 and 3567.6 ± 61.11, respectively, for rifampicin. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 20 ± 0.51 and 60 ± 1.05 ng, respectively, for isoniazid and 25 ± 0.63 and 75 ± 1.12 ng, respectively, for rifampicin. Isoniazid and rifampicin were subjected to acid, base, peroxide, and UV-induced degradation. In stability tests the drugs were susceptible to acid and basic hydrolysis, oxidation and photodegradation. Statistical analysis proved the method is repeatable, selective, and accurate for estimation of isoniazid and rifampicin. Because the method could effectively separate the drugs from their degradation products, it can be used as a stabilityindicating method.

Słowa kluczowe :
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2007
Numer : No. 18
Strony : 168 – 179
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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. ,Sivakumar, T. ,Ivanović, D. ,Pavlova, V. ,Ali, J. , Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs. Acta Chromatographica No. 18/2007