European Journal of Chemistry

Derivative spectrophotometric method for simultaneous determination of ezetimibe and simvastatin in combined tablets



Main Article Content

Bahia Abbas Moussa
Marwa Fadel Mohamed
Nadia Fayek Youssef

Abstract

The introduced study portrays the development and validation of an effortless, speedy and selective first order derivative zero-crossing spectrophotometric method to estimate ezetimibe and simvastatin simultaneously in combined drug products over and above in the presence of ezetimibe alkaline degradation products. Ezetimibe and its alkaline degradates spectra showed zero-crossing point at 249 nm, so the amplitude at 249 nm could be used for calculating the concentration of simvastatin. While simvastatin and ezetimibe alkaline degradates spectra showed a zero-reading value at 261 nm, so ezetimibe could be determined by measuring the amplitude at 261 nm. Regression plots revealed good linear relationships in the concentration range 1-16 µg/mL with accuracy checked by conducting recovery studies; average recovery was 99.61 ± 1.183 and 100.47 ± 1.310 for ezetimibe and simvastatin, respectively. The suggested first derivative spectrophotometric method was successfully applied for the determination of the cited drugs in "Inegy 10/10, 10/20 and 10/40 tablets". Satisfactory results were obtained for the recovery of both drugs and were in good agreement with the labeled amounts.  Method validation was estimated according to USP guidelines.

1_4_348_351_800_01


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Moussa, B. A.; Mohamed, M. F.; Youssef, N. F. Derivative Spectrophotometric Method for Simultaneous Determination of Ezetimibe and Simvastatin in Combined Tablets. Eur. J. Chem. 2010, 1, 348-351.

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References

[1]. Sweetman, S. C. Martindale, The Complete Drug Reference, 36th Edition, The Pharmaceutical Press, London, 2009.

[2]. Brunton, L. L.; Lazo, J. S.; Parker, K. L. Goodman and Gilman's, The Pharmacological Basis of Therapeutics. McGraw-Hill Book Co., New York, NY, 2006.

[3]. Sonawane, S. S.; Shirkhedkar, A. A.; Fursule, R.A.; Surana, S. J. Eurasian J. Anal. Chem. 2006, 1, 31-41.

[4]. Erk, N. Pharmazie 2002, 57, 817-819.
PMid:12561243

[5]. Dhaneshwar, S. S.; Dhaneshwar, S. R.; Deshpande, P.; Patil, M. Acta Chromatogr. 2007, 19, 141-148.

[6]. Dixit, R. P.; Barhate, C. R.; Nagarsenker, M. S. Chromatographia 2008, 67, 101-107.
doi:10.1365/s10337-007-0459-4

[7]. Komsta, L.; Skibinski, R.; Hopkala, H.; Winiarcyzk-Serwacka, M. Chem. Anal. (Warsaw, Pol.) 2007, 52, 771-779.

[8]. Sistla, R.; Tata, V. S. S. K.; Kashyap, Y. V.; Chandrasekar, D.; Diwan, P.V. J. Pharm. Biomed. Anal. 2005, 39, 517-522.
doi:10.1016/j.jpba.2005.04.026
PMid:15936912

[9]. Li, S. J.; Liu, G.Y.; Jia, J.Y.; Li, X.C.; Yu, C. J. Pharm. Biomed. Anal. 2006, 40, 987-992.
doi:10.1016/j.jpba.2005.07.053
PMid:16242881

[10]. Oliveria, P. R.; Brum, L. Jr.; Fronza, M.; Bernard, L. S.; Masiero, S. M. K.; Dalmora, S. L. Chromatographia 2006, 63, 315-320.
doi:10.1365/s10337-006-0749-2

[11]. Singh, S.; Singh, B.; Bahuguna, R.; Wadhwa, L.; Saxena, R. J. Pharm. Biomed. Anal. 2006, 41, 1037-1040.
doi:10.1016/j.jpba.2006.01.030
PMid:16495029

[12]. Oswald, S.; Scheuch, E.; Cascorbi, I.; Siegmund, W. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2006, 830,143-150.
doi:10.1016/j.jchromb.2005.10.034
PMid:16280261

[13]. Ashfaq M.; Ullahkhan I.; Qutab S. S.; Naeemrazzaq S. J. Chil. Chem. Soc. 2007, 52, 1220-1223.

[14]. Basha, S. J. S.; Naveed, S. A.; Tiwari, N. K.; Shashikumar, D.; Muzeeb, S.; Kumar, T. R.; Kumar, N.V.; Rao, N. P.; Srinivas, N.; Mullangi, R.; Srinivas, N. R. J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2007, 853, 88-96.
doi:10.1016/j.jchromb.2007.02.053
PMid:17442643

[15]. Ozaltin, N.; Ucakturk, E. Chromatographia 2007, 66, S87-S91.
doi:10.1365/s10337-007-0303-x

[16]. Doshi, A. S.; Kachhadia, P. K.; Joshi, H. S. Chromatographia 2008, 67, 137-142.
doi:10.1365/s10337-007-0470-9

[17]. Seshachalam, U.; Kothapally, C. B. J. Liq. Chromatogr. Relat. Technol. 2008, 31, 714-721.
doi:10.1080/10826070701854402
PMCid:1176066

[18]. Iwabuchi, H.; Kitazawa, E.; Kobayashi, N.; Watanabe, H.; Kanai, M.; Nakamura, K. Biol. Mass Spectrom. 1994, 23, 540-546.
doi:10.1002/bms.1200230903

[19]. Ochiai, H.; Uchiyama, N.; Imagaki, K.; Hata, S.; Kamei, T. J. chromatogr. B: Biomed. Appl. 1997, 694, 211-217.
doi:10.1016/S0378-4347(97)00091-1

[20]. Jemal, M.; Ouyang, Z.; Powell, M. L. J. Pharm. Biomed. Anal. 2000, 23, 323-340.
doi:10.1016/S0731-7085(00)00309-5

[21]. Zhao, J. J.; Xie, I. H.; Yang, A. Y.; Roadcap, B. A.; Rogers, J. D. J. Mass Spectrom. 2000, 35, 1133-1143.
doi:10.1002/1096-9888(200009)35:9<1133::AID-JMS42>3.0.CO;2-X

[22]. Zhang, N. Y.; Yang, A.; Rogers, J. D.; Zhao, J. J. J. Pharm. Biomed. Anal. 2004, 34, 175-287.
doi:10.1016/j.japna.2003.08.016
PMid:14738932

[23]. Yang, A. Y.; Sun, L.; Musson, D. G.; Zhao, J. J. J. Pharm. Biomed. Anal. 2005, 38, 521-527.
doi:10.1016/j.jpba.2005.01.016
PMid:15925254

[24]. Barrett, B.; Huclova, J.; Borek-Dohalsky, V.; Nemec, B.; Jelinek, I. J. Pharm. Biomed. Anal. 2006, 41, 517-526.
doi:10.1016/j.jpba.2005.11.020
PMid:16377115

[25]. Malenovic, A.; Medenica, M.; Ivanovic, D.; Jancic, B. Chromatographia 2006, 63, S95-S100.
doi:10.1365/s10337-006-0747-4

[26]. Senthamil S. P.; Pal, T. K. J. Pharm. Biomed. Anal. 2009, 49, 780-785.
doi:10.1016/j.jpba.2008.12.031
PMid:19188036

[27]. Dalmora, S. L.; Oliveria, P. R.; Barth, T.; Todeschini, V. J. Anal. Sci. 2008, 24, 499-503.
doi:10.2116/analsci.24.499
PMid:18403842

[28]. Srinivasu, M. K.; Raju, A. N.; Reddy, G. O. J. Pharm. Biomed. Anal. 2002, 29, 715-721.
doi:10.1016/S0731-7085(02)00128-0

[29]. Morris, M. J.; Gilbert, J. D.; Hsieh, J. Y.-K.; Matuszewski, B. K.; Ramjit, H. G.; Bayne, W. F. Biol. Mass Spectrom. 1993, 22, 1-8.
doi:10.1002/bms.1200220102
PMid:8431499

[30]. Raw Material In House Specifications; Glenmark Pharmaceuticals, Mumbai, India, 2003.

[31]. The United States Pharmacopoeia (USP 32) and National Formulary (NF 27); Asian Ed., 2009.

[32]. Morelli, B. J. Pharm. Sci. 1988, 77, 615-621.
doi:10.1002/jps.2600770713
PMid:3171949

[33]. Morelli, B. J. Pharm. Sci. 1988, 77, 1042-1045.
doi:10.1002/jps.2600771211
PMid:3244108

[34]. Morelli, B. J. Pharm. Sci. 1995, 84, 34-37.
doi:10.1002/jps.2600840109
PMid:7714740

[35]. Talsky, G.; Marying, L.; Kreuzer, H. Angew. Chem. Int. Ed. Engl. 1978, 17, 785-799.
doi:10.1002/anie.197807853

[36]. OHaver, T.C. Anal. Chem. 1979, 51, 91A-100A.

[37]. Rojas, F.S.; Ojeda, C.B.; Pavon, J. M.C. Talanta 1988, 35, 753-761.
doi:10.1016/0039-9140(88)80179-6

[38]. http://www.medicines.org.uk/emc/medicine/15657.

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