Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide

Czasopismo : Acta Chromatographica
Tytuł artykułu : Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide

Autorzy :
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,
Joshi, S. S.
National Institute of Pharmaceutical Education and Research (NIPER) Balanagar, Hyderabad 500037 India,
Nahire, R. R.
National Institute of Pharmaceutical Education and Research (NIPER) Balanagar, Hyderabad 500037 India,
Shastri, N. R.
National Institute of Pharmaceutical Education and Research (NIPER) Balanagar, Hyderabad 500037 India, svcphod@yahoo.co.in,
Surendranath, K. V.
ICICI Knowledge Park United States Pharmacopeia India Private Limited, Reference Standard Laboratory Shameerpet, Hyderabad 500078 India,
Satish, J.
ICICI Knowledge Park United States Pharmacopeia India Private Limited, Reference Standard Laboratory Shameerpet, Hyderabad 500078 India,
Abstrakty : A simple, rapid, precise, and accurate, stability-indicating reversed phase high performance liquid chromatographic method was developed and validated for simultaneous determination of metformin HCl and repaglinide. The chromatographic separation was achieved on YMC Pack AM ODS (5 μm, 250 mm length × 4.6 mm i.d.) column at a detector wavelength of 210 nm, using an isocratic mobile phase consisting of methanol and 10 mM potassium dihydrogen phosphate buffer (pH 2.5) in a ratio of 70:30 v/v at a flow rate of 1 mL min-1. The retention times for metformin and repaglinide were found to be 2.6 and 11.3 min, respectively. The drugs were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Validation of the method was carried out as per International Conference on Harmonization (ICH) guidelines. Linearity was established for metformin and repaglinide in the range of 5–200 μg mL-1and 1–200 μg m-1. L, respectively. The limits of detection were 0.3 μg mL-1and 0.13 μg mL-1for metformin and repaglinide, respectively. The method was found to be specific and stability-indicating as no interfering peaks of degradants and excipients were observed. The proposed method is hence suitable for application in quality-control laboratories for quantitative analysis of both the drugs individually and in combination, since it is simple and rapid with good accuracy and precision.

Słowa kluczowe : metformin, repaglinide, reversed-phase HPLC, stability-indicating assay, forced degradation studies, method validation,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2012
Numer : Vol. 24, no. 3
Strony : 419 – 432
Bibliografia : 1 C.J. Bailey and R.C. Turner, N. Eng. J. Med., 334, 574 (1996)
2 S.C. Sweetman (Ed) Martindale The Complete Drug Reference, 36th edn, Pharmaceutical Press, London, 2009, p. 457
3 R.G. Moses, Exp. Clin. Endocrinol Diabetes, 107, S136 (1999)
4 A.E. Bretnall and G.S. Clarke, in: H.G. Brittain (Ed) Analytical Profiles of Drug Substances and Excipients, Academic Press, NY, 1998, vol. 25, pp. 243–258
5 M. Vasudevan, J. Ravi, S. Ravisankar, and B. Suresh, J. Pharm. Biomed. Anal., 25, 77 (2001)
6 B.L. Kolte, B.B. Raut, A.A. Deo, M.A. Bagool, and D.B. Shinde, J. Chromatogr. Sci., 42, 27, (2004)
7 R. Bhanu, S. Kulkarni, and A. Kadam, Indian Drugs, 43, 16 (2006)
8 Zarghi, S.M. Foroutan, A. Shafaati, and A. Khoddam, J. Pharm. Biomed. Anal., 31, 197 (2003)
9 S. AbuRuz, J. Millership, and J. McElnay, J. Chromatogr. B, 817, 277 (2005)
10 M. Gandhimathi, T.K. Ravi and S.K. Renu, Anal. Sci., 9, 1675 (2003)
11 K.V. Reddy, J.M. Babu, V.T. Mathad, S. Eswaraiah, M.S. Reddy, P.K. Dubey, and K. Vyas, J. Pharm. Biomed. Anal., 32, 461 (2003)
12 A. Berecka, A. Gumieniczek, and H. Hopkała, J. AOAC Int., 89, 319 (2006)
13 A.B. Ruzilawati, M.S. Wahab, A. Imran, Z. Ismail, and G.H. Gan, J. Pharm. Biomed. Anal. 43, 1831 (2007)
14 P. Venkatesh, T. Harisudhan, H. Choudhury, R. Mullangi, and N.R. Srinivas, Biomed. Chromatogr., 20, 1043 (2006)
15 J.R. Patel, B.N. Suhagia, and B.H. Patel, Indian J. Pharm. Sci., 69, 844 (2007)
16 International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), Geneva, 2005
17 International Conference on Harmonization (ICH), Stability Testing of New Drug Substances and Products, Q1A(R2), Geneva, 2003
18 S.W. Baertschi (Ed) Pharmaceutical Stress Testing: Predicting Drug Degradation, Taylor & Francis Group, LLC, Boca Raton, FL, 2005
19 C. Yardimci and N. Ozaltin, Chromatographia, 66, 589 (2007)
20 N.C. vande Merbel, G. Wilkens, S. Fowles, B. Oosterhuis, and J.H.G. Jonkman, Chromatographia, 47, 542 (1998)
21 W. Grell, R. Hurnaus, G. Griss, R. Sauter, E. Rupprecht, M. Mark, P. Luger, H. Nar, H. Wittneben, and P. Müller, J. Med Chem., 41, 5219 (1998)
22 M. Bakshi and S.J. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002)
DOI :
Cytuj : 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. ,Joshi, S. S. ,Nahire, R. R. ,Shastri, N. R. ,Surendranath, K. V. ,Satish, J. , Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide. Acta Chromatographica Vol. 24, no. 3/2012
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