European Journal of Chemistry

Stability-indicating HPLC and PLS chemometric methods for the determination of acemetacin in presence of its degradation products and impurities



Main Article Content

Amira Mohamed Kessiba
Maha Abdel Monen Hegazy
Mohamed Mohamed Abdelkawy
Ahmed Emad El Gendy

Abstract

Two stability-indicating methods were developed and validated for the quantitative determination of acemetacin (ACM) in presence of its degradation products and impurities. The first method was based on separation of ACM from its degradation products and impurities by RP-HPLC on Inertsil C8 column (150 × 4.6 mm i.d) using a mobile phase composed of 0.02 M phosphate buffer: methanol (35:65, v:v, pH = 6.5). The flow rate was adjusted at 1 mL/min and quantification was achieved with UV detection at 245 nm using meloxicam as internal standard. The second method was based on multivariate spectrophotometric analysis using partial least square regression model. The drug was subjected to acid, base, oxidative and thermal stress conditions and the degradation products were identified. The developed methods have the requisite accuracy, selectivity, sensitivity and precision to assay ACM in presence of its degradation products and impurities either in bulk powder or in pharmaceutical dosage form. The results obtained for the analysis of ACM in its pure form by the proposed methods were statistically compared to those obtained by applying a reported HPLC method. The statistical comparison showed that there is no significant difference between the proposed methods and the reported one with respect to accuracy and precision.


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Kessiba, A. M.; Hegazy, M. A. M.; Abdelkawy, M. M.; El Gendy, A. E. Stability-Indicating HPLC and PLS Chemometric Methods for the Determination of Acemetacin in Presence of Its Degradation Products and Impurities. Eur. J. Chem. 2015, 6, 422-429.

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References

[1]. Jones, R. W.; Collins, A. J.; Notarianni, L. J.; Sedman, E. Brit. J. Clin. Pharm. 1991, 31, 543-545.
http://dx.doi.org/10.1111/j.1365-2125.1991.tb05577.x

[2]. Hazleman, B.; Bernstein, R. M. Curr. Med. Res. Opin. 1993, 13, 119-126.
http://dx.doi.org/10.1185/03007999309111540

[3]. Chou, C. T.; Tsai, Y. Y. Int. J. Clin. Pharm. Res. 2002, 22, 1-6.
http://dx.doi.org/10.1002/j.1552-4604.1982.tb05701.x

[4]. Heitar, A.; Tausch, G.; Eberi, R. Arzneim Forsch 1980, 30, 1460-1463.

[5]. Lonauer, G.; Wirth, W. Arzneim Forsch 1980, 30, 1440-1444.

[6]. Brackertz, D.; Muller, M. Therapiewoche 1982, 32, 2493-2498.

[7]. Saul, P. A.; Korlipara, K. Curr. Med. Res. Opin. 1991, 12, 332-341.
http://dx.doi.org/10.1185/03007999109112669

[8]. Tavares, I. A.; Bennett, A. Int. J. Tiss. Reac. 1993, 15, 49-53.

[9]. Chavez-Pina, A. E.; McKnight, W.; Dicay, M.; Castaneda-Hernandez, G.; Wallace, J. L. Brit. J. Pharm. 2007, 152, 930-938.
http://dx.doi.org/10.1038/sj.bjp.0707451

[10]. Arcos, M. J.; Ortiz, M. C.; Villahoz, B.; Sarabia, L. A. Anal. Chim. Acta 1997, 339, 63-77.
http://dx.doi.org/10.1016/S0003-2670(96)00438-2

[11]. Castro, B.; Gameiro, P.; Lima, J. L. F. C.; Matos, C.; Reis, S. Mat. Sci. Eng. C 2001, 18, 71-78.
http://dx.doi.org/10.1016/S0928-4931(01)00372-1

[12]. Zouvelekis, D.; Yannakopoulou, K.; Mavridis, I. M.; Antoniadou, V. E. Carb. Res. 2002, 337, 1387-1395.
http://dx.doi.org/10.1016/S0008-6215(02)00174-X

[13]. Auer, M. E.; Griesser, U. J.; Sawatzki, J. J. Mol. Struct. 2003, 661-662, 307-317.
http://dx.doi.org/10.1016/j.molstruc.2003.09.002

[14]. Ozbakan, H.; Palabiyik, I. M.; Caglayan, M. G.; Onur, F. Turk. J. Pharm. Sci. 2009, 6, 163-176.

[15]. Schollnhammer, G.; Dell, H. D.; Doersing, K.; Kamp, R. J. Chrom. B: Biom. Sci. App. 1986, 375, 331-338.

[16]. Notarianni, L. J. J. Chrom. 1987, 413, 305-308.

[17]. Jones, R. W.; Collins, A. J.; Notarianni, L. J.; Sedman, E. Brit. J. Clin. Pharm. 1991, 31, 543-545.
http://dx.doi.org/10.1111/j.1365-2125.1991.tb05577.x

[18]. Hu, Y. Q.; Lui, H. C.; Hou, Y. N.; Wang, J. Chinese J. Clin. Pharm. 1999, 3, 203-205.

[19]. Hu, Y. Q.; Lui, H. C.; Ma, R.; Wang, J.; Hou, Y. N. Se Pu 1999, 17, 586-587.

[20]. Escuder, G. L.; Martin, B. Y.; Sagrado, S.; Villanueva, C. R. M.; Medina, H. M. J. Chromatographia 2002, 55, 283-288.
http://dx.doi.org/10.1007/BF02491660

[21]. Martinez, A. C.; Escuder, G. L.; Sagrado, S.; Villanueva, C. R. M.; Medina, H. M. J. J. Pharm. Biom. Anal. 2004, 36, 393-399.
http://dx.doi.org/10.1016/j.jpba.2004.06.011

[22]. Wei, W.; Yu, X.; Ju, H. J. Chrom. Sci. 2004, 42, 155-160.
http://dx.doi.org/10.1093/chromsci/42.3.155

[23]. Ban, E.; Cho, J. H.; Jang, D. J.; Piao, X. L.; Kim, C. K. J. Liq. Chrom. Rel. Techn. 2005, 28, 1593-1604.
http://dx.doi.org/10.1081/JLC-200058377

[24]. Li, D. M.; Lu, W. L.; Wang, X. Q.; Wang, J. C.; Zhang, H.; Zhang, R. J.; Wang, G. L.; Zhang, X.; Zhang, Q. J. Heal. Sci. 2005, 51, 308-316.
http://dx.doi.org/10.1248/jhs.51.308

[25]. Pina, A. E. C.; Favari, L.; Hernandez, G. C. Ann. Hepat. 2009, 8, 141-147.

[26]. Hu, T.; Peng, T.; Li, X. J.; Chen, D. D.; Dai, H. H.; Deng, X. J.; Yue, Z. F.; Wang, G. M.; Shen, J. Z.; Xia, X.; Ding, S. Y.; Zhou, Y. N.; Zhu, A. L.; Jiang, H. Y. J. Chromatogr. A 2012, 1219, 104-113.
http://dx.doi.org/10.1016/j.chroma.2011.11.009

[27]. Palacios, J. L.; Arcos, J.; Batanero, P. S. J. Pharm. Biom. Anal. 1988, 6, 963-968.
http://dx.doi.org/10.1016/0731-7085(88)80117-1

[28]. Reguera, C.; Arcos, M. J.; Ortiz, M. C. Talanta 1998, 46, 1493-1505.
http://dx.doi.org/10.1016/S0039-9140(98)00024-1

[29]. Reguera, C.; Ortiz, M. C.; Arcos, M. J. Electroanalysis 2002, 14, 1699-1706.
http://dx.doi.org/10.1002/elan.200290013

[30]. Naguib, I. A.; AbdelAleem, E. A.; Zaazaa, H.; Hussein, E. A. Eur. J. Chem. 2014, 5, 219-226.
http://dx.doi.org/10.5155/eurjchem.5.2.219-226.966

[31]. Wold, S.; Sjostrom, M. Chemom. Intel. Lab. Syst. 1998, 44, 3-4.
http://dx.doi.org/10.1016/S0169-7439(98)00075-6

[32]. Lotfy, H. M; Abdel-Monem H. M.; Abdel-Gawad, S. A. Eur. J. Chem. 2013, 4, 414-421.
http://dx.doi.org/10.5155/eurjchem.4.4.414-421.829

[33]. Matlab; Ver. 7.0.1., Mathworks Inc., 2004.

[34]. Barry, M.; Wise & NB. Gallagher; PLS_Toolbox 2.1, Eigenvector Research Inc., 2001.

[35]. Krzek, J.; Starek, M. J. AOAC Int. 2001, 84, 1703-1706.

[36]. Novakova, L.; Matysova, L.; Havlikova, L.; Solich, P. J. Pharm. Biom. Anal. 2005, 37, 899-905.
http://dx.doi.org/10.1016/j.jpba.2004.09.012

[37]. Garcia, B.; Hoyuelos, F. J.; Ibeas, S.; Leal. J. M. J. Org. Chem. 2012, 71, 3718-3726.
http://dx.doi.org/10.1021/jo052561k

[38]. British Pharmacopoeia; British Pharmacopoeia Commission; The stationary Office, 2012.

[39]. Clarke's Analysis of Drugs and Poisons, London: Pharmaceutical Press. Electronic version, 2005.

[40]. Gnehm, R.; Weber, R. Patentgenius 1985, Patent US4503237.

[41]. Lonauer, G.; Wirth, W. Arzneim Forsch 1980, 30, 1440-1444.

[42]. Brackertz, D.; Muller, M. Therapiewoche 1982, 32, 2493-2498.

[43]. Clarke's Analysis of Drugs and Poisons, 3rd ed.; Pharmaceutical press, London, United Kingdom 2004.

[44]. International Conference of Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH), www.nihs.go.jp, Center for Drug Evaluation and Research, U. S. Food and Drug Administration. Reviewer Guidance, Validation of Chromatographic Methods; FDA, Rockville, 1994.

[45]. Lundstedt, T.; Seifert, E.; Abramo, L.; Thelin, B.; Nystrom, A.; Pettersen, J.; Bergman, R. Chemom. Intell. Lab. Syst. 1998, 42, 3-40.
http://dx.doi.org/10.1016/S0169-7439(98)00065-3

[46]. Haaland, D. M.; Thomas, E. V. Anal. Chem. 1988, 60, 1193-1202.
http://dx.doi.org/10.1021/ac00162a020

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