Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method

Czasopismo : Acta Chromatographica
Tytuł artykułu : Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method

Autorzy :
Patil, A. N.
Pravara Rural College of Pharmacy Department of Pharmacognosy Pravaranagar, Loni 413736 Maharashtra India,
Nirmal, S. A.
Pravara Rural College of Pharmacy Department of Pharmacognosy Pravaranagar, Loni 413736 Maharashtra India, nirmalsunil@rediffmail.com,
Chavan, A. K.
Pravara Rural College of Pharmacy Department of Pharmacognosy Pravaranagar, Loni 413736 Maharashtra India,
Zhou, L.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Xu, J.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Luan, L.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Ma, J.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Gong, Y.
Ministry of Agriculture Institute for the Control of Agrochemicals Beijing 100026 China,
Qin, D.
Ministry of Agriculture Institute for the Control of Agrochemicals Beijing 100026 China,
Pan, C.
China Agricultural University Department of Applied Chemistry, College of Science Beijing 100193 China,
Jinlong, M.
Zhejiang University Department of Chemical and Biological Engineering Hangzhou 310027 China,
Guobin, J.
Dalian Nationalities University Environment and Resources College Dalian 11660 China,
Bo, J.
Dalian Nationalities University Life Science College Dalian 116600 China,
Hua, J.
Zhejiang University Department of Chemical and Biological Engineering Hangzhou 310027 China,
Montejo, C.
Universidad CEU San Pablo Departamento de Ciencias Farmacéuticas y de la Alimentación, Área de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia 28668 Madrid Spain, montejo@ceu.es,
Civera, C.
Universidad Complutense de Madrid Departamento de Química Física II, Facultad de Farmacia 28040 Madrid Spain,
Barcia, E.
Universidad Complutense de Madrid Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia 28040 Madrid Spain,
Negro, S.
Universidad Complutense de Madrid Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia 28040 Madrid Spain,
Fernández-Carballido, A.
Universidad Complutense de Madrid Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia 28040 Madrid Spain,
Czauderna, M.
Polish Academy of Sciences The Kielanowski Institute of Animal Physiology and Nutrition 05-110 Jabłonna Poland, mr.czauderna@gmail.com,
Marounek, M.
Prague-Uhříněves The Institute of Animal Science Prague Czech Republic,
Duskova, D.
Prague-Uhříněves The Institute of Animal Science Prague Czech Republic,
Kowalczyk, J.
Polish Academy of Sciences The Kielanowski Institute of Animal Physiology and Nutrition 05-110 Jabłonna Poland,
Konda, R. K.
Hindu College of Pharmacy Department of Pharmaceutical Chemistry Amaravathi Road Guntur Andhrapradesh 522002 India, victory2ravi@yahoo.co.in,
Chandu, B. R.
Donbosco College of Pharmacy Department of Pharmaceutical Sciences Pulladigunta Guntur 522201 India,
Challa, B. R.
Nirmala College of Pharmacy Department of Pharmaceutical Analysis Madras Road Kadapa Andhrapradesh 516002 India, baluchalla_99@yahoo.com,
Chandrasekhar, K. B.
Jawaharlal Nehru Technological University Department of Chemistry Anantapur 515002 India,
Shen, Y.
Jiangsu University School of Pharmacy Zhenjiang China,
Yang, H.
Jiangsu University School of Pharmacy Zhenjiang China,
Xia, G.
Jiangsu University School of Pharmacy Zhenjiang China,
Wang, J.
Jiangsu University School of Pharmacy Zhenjiang China,
Cai, B.
Nanjing University of Chinese Medicine Jiangsu Key Laboratory of Chinese Medicine Processing, SATCM Key Laboratory of Standardization for Chinese Medicine Processing Nanjing China,
Jia, X.
Jiangsu University School of Pharmacy Zhenjiang China, jxiaobin2005@hotmail.com,
Nurulain, S. M.
United Arab Emirates University Department of Pharmacology and Pharmacotherapy Al Ain United Arab Emirates,
Kalász, H.
Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest Hungary, huba.kalasz@gmail.com,
Szegi, P.
Semmelweis University Department of Pharmacodynamics Budapest Hungary,
Kuca, K.
University Hospital Biomedical Research Center Hradec Kralove Czech Republic,
Adem, A.
United Arab Emirates University Department of Pharmacology and Pharmacotherapy Al Ain United Arab Emirates,
Hasan, M. Y. B.
United Arab Emirates University Department of Pharmacology and Pharmacotherapy Al Ain United Arab Emirates,
Hashemi, F.
Semmelweis University Department of Pharmacodynamics Budapest Hungary,
Tekes, K.
Semmelweis University Department of Pharmacodynamics Budapest Hungary,
Sangoi, M. S.
Federal University of Rio Grande do Sul Faculty of Pharmacy 90610-000 Porto Alegre-RS Brazil, maxsilvasangoi@yahoo.com.br,
Wrasse-Sangoi, M.
Federal University of Santa Maria Department of Industrial Pharmacy 97105-900 Santa Maria-RS Brazil,
Hurtado, F. K.
Federal University of Rio Grande do Sul Faculty of Pharmacy 90610-000 Porto Alegre-RS Brazil,
Rolim, C. M. B.
Federal University of Santa Maria Department of Industrial Pharmacy 97105-900 Santa Maria-RS Brazil,
Abstrakty : A sensitive, fast, and stability-indicating micellar electrokinetic chromatographic (MEKC) method was developed and validated for the analysis of aliskiren (ALI) in tablets using nimesulide as internal standard (IS). Optimal conditions for the separation of ALI and its degradation products were investigated. The method employed 60 mM Tris buffer and 50 mM anionic detergent sodium dodecyl sulfate (SDS) solution at pH 9.8. MEKC method was performed on a fused-silica capillary (50 μm id; effective length, 40 cm). The capillary temperature was maintained at 35°C, and the applied voltage was 30 kV, with detection by photodiode array (PDA) detector set at 204 nm. The method was validated in accordance with the International Conference on Harmonisation (ICH) requirements. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using PDA detection. The method was linear over the concentration range of 5–150 μg mL-1(r2 = 0.9996) of ALI. Intraday and interday precision and accuracy evaluated by relative standard deviation, respectively, were lower than 2%. The limit of detection was 1.31 μg mL-1. The method proved to be robust by a one-variable-at-a-time evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI in tablets to support the quality control.

Słowa kluczowe : aliskiren, MEKC, stability-indicating method, stress degradation studies, validation,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2013
Numer : Vol. 25, no. 4
Strony : 711 – 724
Bibliografia : 1 R.E. Schmieder, Hipertens. Riesgo Vasc., 27(6), 245 (2010)
2 S. Lam and M. Choy, Cardiol. Rev., 15(6), 316 (2007)
3 S. Vaidyanathan, V. Jarugula, H.A. Dieterich, D. Howard, and W.P. Dole, Clin. Pharmacokinet., 47(8), 515 (2008)
4 L. Suntornsuk, Anal. Bioanal. Chem., 398, 29 (2010)
5 U. Holzgrabe, D. Brinz, S. Kopec, C. Weber, and Y. Bitar, Electrophoresis, 27, 2283 (2006)
6 L.A. Holland, N.P. Chetwyn, M.D. Perkins, and S.M. Lunte, Pharm. Res., 14, 372 (1997)
7 M.S. Sangoi, L.M. Silva, F.B. D’Avila, and S.L. Dalmora, J. Chromatogr. Sci., 48, 641 (2010)
8 S. El Deeb, M.A. Iriban, and R. Gust, Electrophoresis, 32, 166 (2011)
9 M. Wrasse-Sangoi, M.S. Sangoi, P.R. Oliveira, L.T. Secretti, and C.M.B. Rolim, J. Chromatogr. Sci., 49, 170 (2011)
10 M. Wrasse-Sangoi, L.T. Secretti, I.F. Diefenbach, C.M.B. Rolim, and M.S. Sangoi, Quim. Nova, 33(6), 1330 (2010)
11 M.S. Sangoi, M. Wrasse-Sangoi, P.R. Oliveira, V. Todeschini, and C.M.B. Rolim, J. Liq. Chromatogr. Relat. Technol., 34, 1976 (2011)
12 M.S. Sangoi, M. Wrasse-Sangoi, P.R. Oliveira, C.M.B. Rolim, and M. Steppe, J. Sep. Sci., 34, 1859 (2011)
13 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability testing of New Drug Substances and Products, Q1A(R2), Geneva, August, 2003
14 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology, Q2(R1), Geneva, November, 2005
15 R. Injac, M. Boskovic, N. Kocevar, and T. Vovk, Anal. Chim. Acta, 620, 150 (2008)
16 B. Dejaegher and Y.V. Heyden, J. Chromatogr. A, 1158, 138 (2007)
17 United States Pharmacopeial Convention, The United States Pharmacopeia, 32th ed., Rockville, MD, 2009
18 K.L. See, A.A. Elbashir, B. Saad, A.S.M. Ali, and H.Y. Aboul-Enein, Biomed. Chromatogr., 23, 1283 (2009)
19 K.M. Alsante, A. Ando, R. Brown, J. Ensing, T.D. Hatajik, W. Kong, and Y. Tsuda, Adv. Drug Deliv. Rev., 59, 29 (2007)
20 S. Görög, J. Pharm. Biomed. Anal., 48, 247 (2008)
21 E. Rozet, A. Ceccato, C. Hubert, E. Ziemons, R. Oprean, S. Rudaz, B. Boulanger, and P. Hubert, J. Chromatogr. A, 1158, 111 (2007)
22 G.A. Shabir, J. Chromatogr. A, 987, 57 (2003)
DOI :
Cytuj : Patil, A. N. ,Nirmal, S. A. ,Chavan, A. K. ,Zhou, L. ,Xu, J. ,Luan, L. ,Ma, J. ,Gong, Y. ,Qin, D. ,Pan, C. ,Jinlong, M. ,Guobin, J. ,Bo, J. ,Hua, J. ,Montejo, C. ,Civera, C. ,Barcia, E. ,Negro, S. ,Fernández-Carballido, A. ,Czauderna, M. ,Marounek, M. ,Duskova, D. ,Kowalczyk, J. ,Konda, R. K. ,Chandu, B. R. ,Challa, B. R. ,Chandrasekhar, K. B. ,Shen, Y. ,Yang, H. ,Xia, G. ,Wang, J. ,Cai, B. ,Jia, X. ,Nurulain, S. M. ,Kalász, H. ,Szegi, P. ,Kuca, K. ,Adem, A. ,Hasan, M. Y. B. ,Hashemi, F. ,Tekes, K. ,Sangoi, M. S. ,Wrasse-Sangoi, M. ,Hurtado, F. K. ,Rolim, C. M. B. , Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method. Acta Chromatographica Vol. 25, no. 4/2013
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