Journal : Acta Chromatographica
Article : High-performance thin-layer chromatographic method for determination of erdosteine in pharmaceutical dosage forms

Authors :
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,
Popović, G.
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, P.O. Box 146, 11000 Belgrade, Serbia,
Mhaske, D. V.
Department of Quality Assurance Techniques and Pharmaceutical Chemistry, Bharati Vidyapeeth University, Poona College of Pharmacy, Centre for Advanced Pharmaceutical Research, Erandwane, Pune 411038, Maharashtra State, India,
Abstract : A sensitive, selective, precise, and stability-indicating method for quantitative analysis of erdosteine, in the presence of its degradation products, both as the bulk drug and in a formulation has been established and validated. High-performance thin layer chromatography (HPTLC) on aluminium-backed silica gel 60 F254 plates with toluene–methanol–acetone–ammonia 3.5:3.5:2.5:0.05 (v/v) as mobile phase was followed by densitometric measurement at 254 nm. This system was found to give compact bands for erdosteine (RF 0.45 ± 0.02). The method was validated in accordance with ICH guidelines There was no chromatographic interference from capsule excipients. Erdosteine was subjected to acid and alkaline hydrolysis, oxidation, dry heat, wet heat, and UV degradation. The drug is degraded by acid and alkaline hydrolysis, oxidation, and UV irradiation. The drug was found to be stable under wet and dry heat conditions. Because the method could effectively separate the drug from its degradation products it can be regarded as stability-indicating.

Keywords :
Publishing house : University of Silesia in Katowice
Publication date : 2007
Number : No. 19
Page : 170 – 184

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Qute : 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. ,Popović, G. ,Mhaske, D. V. ,Mhaske, D. V. , High-performance thin-layer chromatographic method for determination of erdosteine in pharmaceutical dosage forms. Acta Chromatographica No. 19/2007