HPTLc method development and validation for analysis of risperidone in formulations, and in-vitro release study

• Autorzy: Patel R. B , Patel B. G , Patel M. R , Bhatt K. K
• Języki publikacji: EN

Abstrakty

EN

A new, simple, and rapid high-performance thin-layer chromatographic method has been established for quantitative analysis of risperidone. Chromatography was performed on silica gel 60 F 254 plates with methanol-ethyl acetate 8.0:2.0 ( v / v ) as mobile phase. Risperidone was quantified by densitometric analysis at 285 nm. The method gave compact bands for the drug ( R F 0.34 ± 0.01). Linear regression analysis of calibration data revealed a good linear relationship ( r 2 = 0.9996) between response and amount of risperidone in the range 100–600 ng per band. The method was validated for precision, recovery, repeatability, linearity, specificity, and robustness in accordance with ICH guidelines. The minimum detectable amount was 22.44 ng per band and the limit of quantification was 68.01 ng per band. Statistical analysis of the results showed the method enabled precise, accurate, reproducible, and selective analysis of risperidone. The method was successfully used for estimation of the equilibrium solubility of risperidone, and for quantification of risperidone as the bulk drug in a commercially available preparation, in in-house-developed mucoadhesive microemulsion formulations, and in solution.

Słowa kluczowe

EN

equilibrium solubility; HPTLC; in-vitro diffusion; mucoadhesive microemulsion; risperidone; pH-solubility profile

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2010
• Tom: Vol. 22, no. 4
• Strony: 549--567
• Opis fizyczny: Bibliogr. 50 poz., rys., tab.

Twórcy

autor

Patel R. B

• Sardar Patel University R. College of Pharmacy and G. H. Patel Institute of Pharmacy Vallabh Vidyanagar 388 120 India

autor

Patel B. G

• Sardar Patel University R. College of Pharmacy and G. H. Patel Institute of Pharmacy Vallabh Vidyanagar 388 120 India

autor

Patel M. R

• Sardar Patel University Indukaka Ipcowala College of Pharmacy New Vallabh Vidyanagar 388 121 India

autor

Bhatt K. K

• Sardar Patel University Indukaka Ipcowala College of Pharmacy New Vallabh Vidyanagar 388 121 India

Bibliografia

• [1] J. Carman, J. Peuskens, and A. Vangeneugden, Int. Clin. Psychopharmacol., 10 , 207–213 (1995)
• [2] H. He and J.S. Richardson, Int. Clin. Psychopharmacol., 10 , 19–30 (1995)
• [3] A.A. Megens, F.H. Awouters, A. Schotte, T.F. Meert, C. Dugovic, C.J. Niemegeers, and J.E. Leysen, Psychopharmacology, 114 , 9–23 (1993)
• [4] C.R. Behl, H.K. Pimplaskar, A.P. Sileno, J. De Meireles, and V.D. Romeo, Adv. Drug Del. Rev., 29 , 89–116 (1998)
• [5] L.G. Candace and G.M. Pollock, J. Pharm. Sci., 94 , 187–195 (2005)
• [6] H.S. Chow, Z. Chen, and G.T. Matsuura, J. Pharm. Sci., 88 , 754–758 (1999)
• [7] T.K. Vyas, A.K. Babber, R.K. Sharma, S. Singh, and A. Misra, J. Pharm. Sci., 95 , 570–580 (2006)
• [8] L. Li, I. Nandi, and K.H. Kim, Int. J. Pharm., 237 , 77–85 (2002)
• [9] S. Mathison, R. Nagilla, and U.B. Kompella, J. Drug Target, 56 , 415–441 (1998)
• [10] R. Pietrowky, A. Thieman, W. Kern, H.L. Fehm, and J. Bern, Psychoneuroendocrinology, 21 , 559–572 (1996)
• [11] Z. Qizhi, X. Jiang, W. Xiang, W. Lu, L. Su, and Z. Shi, Int. J. Pharm., 275 , 85–96 (2004)
• [12] M.J. Lawrence and G.D. Rees, Adv. Drug Deliv. Rev., 45 , 89–121 (2000)
• [13] K.E. Goeringa, I.M. McIntyre, and O.H. Drunmer J. Anal. Toxicol., 27 , 30–35 (2003)
• [14] D. Thieme and H. Saches, J. Anal. Chim. Acta, 492 , 171–186 (2003)
• [15] A. Pelander, I. Ojanpera, S. Laks, I. Rasanen, and E. Vuori, J. Anal. Chem., 75 , 5710–5718 (2003)
• [16] A.E. Balant-Gorgia, M. Gex-Fabry, C. Genet, and L.P. Balant, J. Ther. Drug Monit., 21 , 105–115 (1999)
• [17] M. Aravagiri, S.R. Marder, T. Van-Putten, and K.K. Midha, J. Pharm. Sci., 82 , 447–449 (1993)
• [18] A.C. Springfield and E. Bodiford, J. Anal. Toxicol., 20 , 202–203 (1996)
• [19] G. Casamenti, R. Mandrioli, C. Sabbioni, F. Bugamelli, V. Volterra, and M.A. Raggi, J. Chromatogr. Relat. Technol., 23 , 1039–1059 (2000)
• [20] M.A. Raggi, G. Casamenti, R. Mandrioli, C. Sabbioni, and V. Volterra, J. Pharm. Biomed. Anal., 23 , 161–167 (2000)
• [21] M. Andersson, U.K. Hultin, and A. Sokolowski, Chromatographia, 48 , 770–776 (1998)
• [22] R. Woestenborghs, W. Lorreyne, F. Van Rompaey, and J. Heykants, J. Chromatogr. Biomed. Appl., 121 , 223–230 (1992)
• [23] J.P. Le-Moing, S. Edouard, and J.C. Levron, J. Chromatogr. Biomed. Appl., 125 , 333–339 (1993)
• [24] O.V. Olesen and K. Linnet, J. Chromatogr. Biomed. Appl., 698 , 209–216 (1997)
• [25] M.C. Price and D.W. Hoffman, J. Ther. Drug Monit., 19 , 333–337 (1997)
• [26] M. Aravagiri, S.R. Marder, D. Wirshing, and W. C. Wirshing, Pharmacopsychiatry, 31 , 102–109 (1998)
• [27] T. Nagasaki, T. Ohkubo, K. Sugawara, N. Yasui, H. Furukori, and S. Kaneko, J. Pharm. Biomed. Anal., 19 , 595–601 (1999)
• [28] H. Xiao, J. Yang, S.N. Zhang, and X.B. Zhang, Sepu, 17 , 395–396 (1999)
• [29] A. Avenoso, G. Facciola, M. Salemi, and E. Spina, J. Chromatogr. B Biomed. Sci. Appl., 746 , 173–181 (2000)
• [30] D.S. Schatz and A. Saria, Pharmacology, 60 , 51–56 (2000)
• [31] C. Frahnert, M.L. Rao, and K. Grasmaeder, J. Chromatogr. B Anal, Technol. Biomed. Life Sci., 794 , 35–47 (2003)
• [32] K. Titier, S. Bouchet, F. Pehourcq, N. Moore, and M. Molimard, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 799 , 179–183 (2003)
• [33] K. Titier, E. Deridet, E. Cardone, A. Abouelfath, and N. Moore, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 772 , 373–378 (2002)
• [34] Y.L. Shen, H.L. Wu, W.K. Ko, and S.M. Wu, J. Anal. Chim. Acta, 460 , 201–208 (2002)
• [35] A. Lierena, R. Berecz, P. Dorado, C. Sanz-de-la-Garza, M.J. Norberto, M. Caceres, and J.R. Gutierrez, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 783 , 213–219 (2003)
• [36] B.M.M. Remmerie, L.L.A. Sipes, R. De-Vries, J. De-Jong, A.M. Schothuis, E.W.J. Hooi Jschuur, and N.C. Van-de-Merbel, J. Chromatogr. B Anal. Technol., Biomed. Life Sci., 783 , 461–472 (2003)
• [37] M. Aravagiri and S.R. Marder, J. Mass Spectrom., 35 , 718–724 (2000)
• [38] S. McClean, E.J. O’Kane, and W.F. Smyth, J. Chromatogr B Biomed. Appl., 740 , 141–157 (2000)
• [39] M. Gergov, I. Ojanpera, and E. Vuori, J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 795 , 41–53 (2003)
• [40] A. Pelander, I. Ojanpera, J. Sistonen, I. Rasanen, and E. Vuori, J. Anal., Toxicol., 27 , 226–232 (2003)
• [41] J. Schuberth, J. Anal. Chem., 68 , 1317–1320 (1996)
• [42] H.H. Maurer, T. Kraemer, C. Kratzsch, F.T. Peters, and A.A. Weber, J. Ther. Drug Monit., 24 , 117–124 (2002)
• [43] V. Pucci, M.A. Raggi, and E. Kenndler, J. Liq. Chromatogr. Relat. Technol., 23 , 25–34 (2000)
• [44] V. Pucci, M.A. Raggi, and E. Kenndler, J. Chromatogr. B Biomed. Appl., 728 , 263–271 (2000)
• [45] X.F. Zhu, S. Thiam, B.C. Valle, and I.M. Warner, J. Anal. Chem., 74 , 5405–5409 (2002)
• [46] Z.A. El-Sherif, B. El-Zeany, and O.M. El-Houssini, J. Pharm. Biomed. Anal., 36 , 975–981 (2005)
• [47] R.B. Patel, A.B. Patel, M.R. Patel, M.B. Shankar, and K.K. Bhatt, Anal. Lett., 42 , 1588–1602 (2009)
• [48] V.B. Borhade, H.A. Nair, D.D. Hegde, and C.R. Barhate, Drug Dev. Ind. Pharm., 35 , 440–448 (2009)
• [49] R.B. Patel, M.R. Patel, M.B. Shankar, and K.K. Bhatt, J. AOAC Int., 91 , 750–755 (2008)
• [50] Validation of Analytical Procedure: Methodology Q2 (R1) International Conference on Harmonization (ICH), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Geneva, Switzerland, 1996