Journal : Acta Chromatographica
Article : Development and validation of an RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms

Authors :
Komsta, Ł.
Medical University of Lublin Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland, lukasz.komsta@am.lublin.pl,
Zięba, A.
The Medical University of Silesia Department of Organic Chemistry ul. Jagiellońska 4 41-200 Sosnowiec Poland, zieba@edu.sum.pl,
Prus, W.
he University of Bielsko-Biała Institute of Environmental Protection and Engineering ul. Willowa 2 43-309 Bielsko-Biała Poland,
Pacenti, M.
University of Florence Occupational Health Division, Department of Public Health Viale Morgagni 48 50100 Florence Italy,
Dugheri, S.
University of Florence Occupational Health Division, Department of Public Health Viale Morgagni 48 50100 Florence Italy,
Gagliano-Candela, R.
University of Bari Forensic Toxicology Division, Department of Internal Medicine and Public Health P.zza G. Cesare 11 70124 Bari Italy,
Strisciullo, G.
University of Bari Forensic Toxicology Division, Department of Internal Medicine and Public Health P.zza G. Cesare 11 70124 Bari Italy,
Franchi, E.
University of Florence Organic Chemistry Department/ProtEra Srl (Spin Off of Magnetic Resonance Center) Via Lastruccia 13 50019 Sesto Fiorentino, Florence Italy,
Degli Esposti, F.
Chromline Srl Via Anita Garibaldi 40 59100 Prato Italy,
Perchiazzi, N.
Chromline Srl Via Anita Garibaldi 40 59100 Prato Italy,
Boccalon, P.
University of Florence Occupational Health Division, Department of Public Health Viale Morgagni 48 50100 Florence Italy,
Arcangeli, G.
University of Florence Occupational Health Division, Department of Public Health Viale Morgagni 48 50100 Florence Italy,
Cupelli, V.
University of Florence Occupational Health Division, Department of Public Health Viale Morgagni 48 50100 Florence Italy,
Szőke, É.
Semmelweis University Department of Pharmacognosy Budapest Hungary,
Petroianu, G.
Florida International University Department of Cell Biology Miami FL USA,
Tekes, K.
Semmelweis University Department of Pharmacodynamics Nagyvárad tér 4 1089 Budapest Hungary, drtekes@gmail.com,
Benkő, B.
Division of Pharmacology and Drug Safety Richter Gedeon Rt. Budapest Hungary,
Szegi, P.
Semmelweis University Department of Pharmacodynamics Nagyvárad tér 4 1089 Budapest Hungary,
Laufer, R.
Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest Hungary,
Veress, G.
State Cardiology Hospital Balatonfüred Hungary,
Kuśmierek, K.
Military University of Technology Institute of Chemistry 2 Kaliskiego Str. 00-908 Warsaw Poland,
Bald, E.
University of Lodz Department of Environmental Chemistry 163 Pomorska Str. 90-236 Lodz Poland, ebald@uni.lodz.pl,
Ravi, S.
University of Science Malaysia School of Pharmaceutical Sciences 11800 Pulau Penang Malaysia ravigdk2002@yahoo.co.uk, ravigdk2002@yahoo.co.uk,
Darwis, Y.
University of Science Malaysia School of Pharmaceutical Sciences 11800 Pulau Penang Malaysia ravigdk2002@yahoo.co.uk,
Abstract : An isocratic RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms has been developed and validated. Best separation was achieved on a Thermo Hypersil C4 column (250 mm × 4.6 mm, 5 µm) using a mobile phase of 20 mM potassium dihydrogen phosphate adjusted to pH 4.0 with orthophosphoric acid and acetonitrile (65:35, v/v) at a flow rate of 1.0 mL min-1. UV detection was performed at 227 nm. The method was validated for specificity, linearity, precision, accuracy, limit of quantification, limit of detection, robustness, and solution stability. The calibration plot was linear over the concentration range 25–600 ng mL-1(r2= 0.9998) and the limits of detection and quantification were 10 and 25 ng mL-1, respectively. Intra-day and inter-day precision and accuracy were between 1.25 and 2.95% and between −1.15 and 2.47%, respectively. The method was successfully used for analysis of sumatriptan succinate, in the presence of excipients, in orally disintegrating tablets prepared in our laboratory and in commercially available tablets (Imigran) and nasal spray (Suminat).

Keywords : sumatriptan succinate, RP-HPLC-UV, method validation, pharmaceutical dosage forms,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 3
Page : 421 – 432

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DOI :
Qute : Komsta, Ł. ,Zięba, A. ,Prus, W. ,Pacenti, M. ,Dugheri, S. ,Gagliano-Candela, R. ,Strisciullo, G. ,Franchi, E. ,Degli Esposti, F. ,Perchiazzi, N. ,Boccalon, P. ,Arcangeli, G. ,Cupelli, V. ,Szőke, É. ,Petroianu, G. ,Tekes, K. ,Benkő, B. ,Szegi, P. ,Laufer, R. ,Veress, G. ,Kuśmierek, K. ,Bald, E. ,Ravi, S. ,Darwis, Y. ,Darwis, Y. , Development and validation of an RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms. Acta Chromatographica Vol. 21, no. 3/2009
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