Journal : Acta Chromatographica
Article : Development and validation of stability-indicating HPLC method for solifenacin succinate: Isolation and identification of major base degradation product

Authors :
Bhushan, R.
Indian Institute of Technology Roorkee Department of Chemistry Roorkee 247667 India, rbushfcy@iitr.ernet.in,
Dixit, S.
Indian Institute of Technology Roorkee Department of Chemistry Roorkee 247667 India,
Mátyus, M.
Hungarian Defence Forces Dr György Radó Military Medical Center Budapest Hungary,
Kocsis, G.
Hungarian Defence Forces Dr György Radó Military Medical Center Budapest Hungary,
Boldis, O.
Hungarian Defence Forces Dr György Radó Military Medical Center Budapest Hungary,
Karvaly, G.
Scientific Institute Military Hospital-State Health Centre P.O. Box 1 H-1553 Budapest Hungary,
Magyari, E.
Hungarian Defence Forces Dr György Radó Military Medical Center Budapest Hungary,
Fűrész, J.
Scientific Institute Military Hospital-State Health Centre P.O. Box 1 H-1553 Budapest Hungary,
Gachályi, A.
Hungarian Defence Forces Dr György Radó Military Medical Center Budapest Hungary,
Mantovani, L.
Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil,
Sayago, C. T. M.
Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil,
Camargo, V. B.
Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil,
Silveira, V. F.
Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil,
Garcia, C. V.
Universidade Federal do Rio Grande do Sul Programa de Pós-graduação em Ciências Farmacêuticas Av. Ipiranga 2752 Lab 402 CEP 90610-000 Porto Alegre-RS Brazil,
Schapoval, E. E. S.
Universidade Federal do Rio Grande do Sul Programa de Pós-graduação em Ciências Farmacêuticas Av. Ipiranga 2752 Lab 402 CEP 90610-000 Porto Alegre-RS Brazil,
Mendez, A. S. L.
Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil, andreaslmendez@yahoo.com.br,
Cao, L.-W.
Jinan University Department of Chemistry Guangzhou 510632 People’s Republic of China, lwcao@126.com,
Li, C.
Jinan University Department of Chemistry Guangzhou 510632 People’s Republic of China,
Desai, D.
The Maharaja Sayajirao University of Baroda Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Pharmacy Building, Donor’s Plaza Fatehgunj, Vadodara 390 002 Gujarat India,
Patel, G.
The Maharaja Sayajirao University of Baroda Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Pharmacy Building, Donor’s Plaza Fatehgunj, Vadodara 390 002 Gujarat India,
Shukla, N.
The Maharaja Sayajirao University of Baroda Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Pharmacy Building, Donor’s Plaza Fatehgunj, Vadodara 390 002 Gujarat India,
Rajput, S.
The Maharaja Sayajirao University of Baroda Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Pharmacy Department, G. H. Patel Pharmacy Building, Donor’s Plaza Fatehgunj, Vadodara 390 002 Gujarat India, sjrajput@gmail.com,
Abstract : Stability-indicating HPLC method was developed for determination of solifenacin succinate (SLN) as bulk drug and from pharmaceutical formulation. The HPLC separation of SLN from its degradation products was achieved using Oyster BDS C8 (250 mm × 4.6 mm i.d., 5 μm particle size) column with a flow rate 0.7 mL min-1and using a UV detector to monitor the eluate at 210 nm. The mobile phase was composed of 10 mM ammonium formate buffer (adjusted pH 3 with formic acid)-acetonitrile-methanol (52.5:37.5:10, v/v/v). The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9999 in the working concentration range of 2–100 μg mL-1. The limit of detection (LOD) and limit of quantification (LOQ) were 0.07 and 0.21 μg mL-1, respectively. API and formulation of SLN were subjected to acid and alkali hydrolysis, oxidation, thermal and photodegradation. Standard drug peak was well resolved from the peaks of degradation products with significantly different retention time values. Also, isolation and identification of major base degradation product were carried out. The method is simple, accurate, specific, repeatable, stability-indicating, reduces the duration of the analysis and is suitable for routine determination of SLN in pharmaceutical formulation.

Keywords : solifenacin, stability-indicating, liquid chromatography, degradation, validation,
Publishing house : University of Silesia in Katowice
Publication date : 2012
Number : Vol. 24, no. 3
Page : 399 – 418

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DOI :
Qute : Bhushan, R. ,Dixit, S. ,Mátyus, M. ,Kocsis, G. ,Boldis, O. ,Karvaly, G. ,Magyari, E. ,Fűrész, J. ,Gachályi, A. ,Mantovani, L. ,Sayago, C. T. M. ,Camargo, V. B. ,Silveira, V. F. ,Garcia, C. V. ,Schapoval, E. E. S. ,Mendez, A. S. L. ,Cao, L.-W. ,Li, C. ,Desai, D. ,Patel, G. ,Shukla, N. ,Rajput, S. ,Rajput, S. , Development and validation of stability-indicating HPLC method for solifenacin succinate: Isolation and identification of major base degradation product. Acta Chromatographica Vol. 24, no. 3/2012
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