Validated TLC method for simultaneous quantitation of atorvastatin, ezetimibe, and fenofibrate in bulk drug and formulations

• Autorzy: Nikalje A. G , Choudhari V. P
• Języki publikacji: EN

Abstrakty

EN

This article describes a new, simple, precise and accurate TLC method for simultaneous quantitation of atorvastatin (ATO), ezetimibe (EZE), and fenofibrate (FEN) as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisting of chloroform-toluene-methanol-acetic acid 6:3:0.5:0.15 (υ/υ/υ/υ). Densitometric evaluation of the separated zones was performed at 263 nm. The drugs were satisfactorily resolved with RF values of 0.16 ± 0.02, 0.22 ± 0.02, and 0.76 ± 0.02 for ATO, EZE, and FEN, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (75–375 ng per spot for ATO, 99–594 ng per spot for EZE, and 66–330 ng per spot for FEN), precision intra-day and inter-day RSD values were always less than 1.51 for the titled drugs, accuracy (99.72 ± 0.75% for ATO, 101.25 ± 0.91% for EZE, and 101.06 ± 0.60% for FEN), and specificity, in accordance with ICH guidelines.

Słowa kluczowe

EN

atorvastatin; ezetimibe; fenofibrate; thin layer chromatography; validation and quantification

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2011
• Tom: Vol. 23, no. 2
• Strony: 267--280
• Opis fizyczny: Bibliogr. 49 poz., rys., tab.

Twórcy

autor

Nikalje A. G

• Maulana Azad Research Centre Dr. Rafique Zakaria Campus Rauza Bagh, Aurangabad Maharashtra 431001 India

autor

Choudhari V. P

• Maharashtra Institute of Pharmacy Pharmaceutical Analysis and Quality Assurance Department MIT Campus, Paud Road Kothrud, Pune Maharashtra 411038 India

Bibliografia

• [1] Remington, The Science and Practice of Pharmacy, 21st edn., Lippincott Williams & Wilkins, New York, 2006, pp. 1368
• [2] Martindale, The Complete Drug Reference, 32nd edn., Pharmaceutical Press, London, 1999, pp. 1268
• [3] P.S. Sever, N.R. Poulter, B. Dahlof, and H. Wedel. Am. J. Cardiol., 96, 39–44 (2005)
• [4] C. Newman, J. Tsai, M. Szarek, D. Luo, and E. Gibson. Am. J. Cardiol., 97, 61–67 (2006)
• [5] P.N. Dhabale and D.S. Gharge. Int. J. Chem. Technol. Res., 2, 325–328 (2010)
• [6] K.V. Nagaraj and R. Mashru. Anal. Sci., 23, 445–451 (2007)
• [7] A.A. Shirkhedkar and S.J. Surana. J. Planar Chromatogr., 22, 355–358 (2009)
• [8] S.S. Dhaneshwar, S.R. Dhaneshwar, P. Deshpande, and M. Patil. Acta Chromatogr., 19, 141–148 (2007)
• [9] K.R. Rajeshwari, G.G. Sankar, A.L. Rao, and J.V.L.N. Sesahgirirao. IJPS, 68, 275–277 (2006)
• [10] A. Mohammadia, N. Rezanour, M.A. Dogahehc, F.G. Bidkorbeh, M. Hashemb, and R.B. Walker. J. Chromatogr. B, 846, 215–221 (2007)
• [11] H.J. Panchal, B.N. Suhagia, N.J. Patel, I.S. Rathod, and B.H. Patel. Chromatographia, 69, 91–95 (2009)
• [12] S.Q. Syed, N.R. Syed, I.U. Khan, M. Ashfaq, and Z.A. Shuja. J. Food Drug Anal., 5, 139–144 (2007)
• [13] A.A. Kadav and D.N. Vora. J. Pharm. Biomed. Anal., 48, 120–126 (2008)
• [14] S. Ertürk, E.S. Aktas, L. Ersoy, S. Fıcıcıoğlu. J. Pharm. Biomed. Anal., 33, 1017–1023 (2003)
• [15] G. Bahrami, B. Mohammadi, S. Mirzaeei, and A. Kiani. J. Chromatogr. B, 826, 41–45 (2005)
• [16] A. Jamshidi and A.R. Nateghi. Chromatographia, 65, 763–766 (2007)
• [17] V. Bořek-Dohalský, J. Huclová, B. Barrett Němec, I. Ulč, and I. Jelínek. Anal. Bioanal. Chem., 386, 275–285 (2006)
• [18] M. Hermann, H. Christensen, and J.L.E. Reubsaet. Anal. Bioanal. Chem., 382, 1242–1249 (2005)
• [19] D. Skorda and C.G. Kontoyannis. Talanta, 74, 1066–1070 (2008)
• [20] S. Mazurek and R. Szostak. J. Pharm. Biomed. Anal., 49, 168–172 (2009)
• [21] B. Kerzner, J. Corbelli, S. Sharp, L. Lipka, L. Melani, A. LeBeaut, R. Suresh, P. Mukhopadhyay, and E.P. Veltri. J. Am. Coll. Cardiol., 91, 418–424 (2003)
• [22] L. Melani, R. Mills, D. Hassman, R. Lipetz, L. Lipka, A. LeBeaut, R. Suresh, P. Mukhopadhyay, and E. Veltri. Eur. Heart J., 24, 717–728 (2003)
• [23] M. Sharma, D.V. Mhaske, M. Mahadik, S.S. Kadam, and S.R. Dhaneshwar. IJPS, 70, 258–260 (2008)
• [24] B.G. Chaudhari, N.M. Patel, P.B. Shah, and K.P. Modi. IJPS, 68, 793–796 (2006)
• [25] S.S. Dhaneshwar, P. Deshpande, M. Patil, G. Vadnerkar, and S.R. Dhaneshwar. Acta Chromatogr., 20, 71–79 (2008)
• [26] M.V. Mahadik and S.R. Dhaneshwar. Asian J. Pharm. Sci., 2, 182–190 (2007)
• [27] R.P. Dixit, C.R. Barhate, and M.S. Nagarsenker. Chromatographia, 67, 101–107 (2008)
• [28] R. Sistla, V.S.S.K. Tata, Y.V. Kashyap, D. Chrasekar, and P.V. Diwan. J. Pharm. Biomed. Anal., 39, 517–522 (2005)
• [29] S.K. Akmar, L. Kothapalli, A. Thomas, S. Jangam, and A.D. Deshpande. Indian J. Pharm. Sci., 69, 605–697 (2007)
• [30] D.A. Kumar, D.P. Sujan, V. Vijayasree, and J.V.L.N.S. Rao. Eur. J. Chem., 6, 541–544 (2009)
• [31] J. Reddy Sama, R.R. Kalakuntl, V.S.N. Rao, and P. Reddann. J. Pharm. Sci. Res., 2, 82–89 (2101)
• [32] S.S. Sonawane, A.A. Shirkhedkar, R.A. Fursule, and S.J. Surana. Eur. J. Anal. Chem., 1, 31–41 (2006)
• [33] M. Hefnawy, M. Al-Omar, and S. Julkhuf. J. Pharm. Biomed. Anal., 50, 527–534 (2009)
• [34] N. Özaltın and E. Uçaktürk. Chromatographia, 66, 87–91 (2007)
• [35] S. Pandey and M. Rathanand. IJPSRR, 1, 53–57 (2010)
• [36] A.S. Doshi, P.K. Kachhadia, and H.S. Joshi. Chromatographia, 67, 137–141 (2008)
• [37] B.G. Chaudhari, N.M. Patel, P.B. Shah, L.J. Patel, and V.P. Patel. J. AOAC, 90, 1539–1546 (2007)
• [38] P.R. Oliveira, L.B. Junior, L.S. Fronza, M Bernardi, S.M.K. Masiero, and S.L. Dalmora. Chromatographia, 63, 315–320 (2006)
• [39] L. Shuijun, L. Gangyi, J. Jingying, L. Xiaochuan, and Y. Chen. J. Pharm. Biomed. Anal., 40, 987–992 (2006)
• [40] S. Oswald, E. Scheuch, I. Cascorbid, and W. Siegmund. J. Chromatogr. B, 830, 143–150 (2006)
• [41] S.L. Dalmora, P.R. Oliveira, T. Barth, and V. Todeschini. Anal. Sci., 24, 499–503 (2008)
• [42] http://wwwrxlistcom/cgi/generic/antarahtm
• [43] United States Pharmacopoeia 32 (USP 32) (2009) United States Pharmacopeia Convention: Rockville, pp 2351.
• [44] The British Pharmacopoeia (2007) British Pharmacopoeial Commission, London, Vol II, pp. 854
• [45] A. El-Gindy, S. Emara, M.K. Mesbah, and G.M. Hadad. Il Farmaco, 60, 425–438 (2005)
• [46] E. Rozet, B. Mertens, W. Dewe, A. Ceccato, B. Govaerts, B. Boulanger, P. Chiap, B. Streel, J. Crommen, and Ph. Hubert. J. Pharm. Biomed. Anal., 42, 64–70 (2006)
• [47] M.T. Zzaman, S.A. Khan, A. Arora, and O. Ahmad. Electron J. Biomed., 3, 41–54 (2009)
• [48] P.M. Lacroix, B.A. Dawson, R.W. Sears, D.B. Black, T.D. Cyr, and J.C. Ethier. J. Pharm. Biomed. Anal., 18, 383–402 (1998)
• [49] ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization, Geneva, 2005