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Development and validation of a method for simultaneous densitometric analysis of simvastatin and ezetimibe as the bulk drugs and in the tablet dosage form

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Simvastatin is a selective HMG-CoA reductase inhibitor and ezetimibe has lipid-lowering activity. Both are potential anti-lipidemic agents used in combination to reduce the amount of cholesterol and triglycerides in systemic circulation. This paper describes a simple, precise, and accurate HPTLC method for simultaneous estimation of the compounds as the bulk drugs and in the tablet dosage form. Chromatographic separation was performed on aluminium-backed silica gel 60 F254 plates with 8:2 (v/v) toluene- 2-propanol as mobile phase. The separated spots were densitometrically evaluated at 240 nm. The drugs were satisfactorily resolved with RF values 0.48 š 0.01 and 0.53 š 0.01 for simvastatin and ezetimibe, respectively. The accuracy and reliability of the method were assessed by determination of validation data for linearity (0.4-2.0 µg per spot for both simvastatin and ezetimibe), precision (intra-day RSD 0.51-1.04%, inter-day RSD 0.34-1.11% for simvastatin; intra-day RSD 0.47-0.61%, inter-day RSD 0.31-0.61% for ezetimibe), accuracy (98.50 š 0.23 for simvastatin and 98.99 š 0.38 for ezetimibe), and specificity, in accordance with ICH guidelines. The proposed method can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of simvastatin and ezetimibe as the bulk drugs and in tablet formulations.
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Bibliogr. 10 poz., rys., tab.
  • Bharati Vidyapeeth University Department of Pharmaceutical Chemistry, Poona College of Pharmacy Erandwane, Pune 411 038 India
  • [1] html (accessed on 01/04/08)
  • [2] (accessed on 01/04/08)
  • [3] M. Gandhimathi, T.K. Ravi, A. Varghese, and A. Ninan, Indian Drugs, 40, 707 (2003)
  • [4] R. Godoy, C. Godoy, and M. de Diego, J. Chil. Chem. Soc., 49, 289 (2004)
  • [5] B. Barrett, J. Huclova, V. Borek-Dohalsky, B. Nemec, and I. Jelinek, J. Pharm. Biomed. Anal., 41, 517 (2006)
  • [6] L. Wang and M. Asgharnejad, J. Pharm. Biomed. Anal., 21, 1243 (2000)
  • [7] G. Carlucci and P Mazzeo, Farmaco, 47, 817 (1992)
  • [8] S.N. Meyyanathan, G.V.S. Ramasarma, and B. Suresh, Ars. Pharm., 45, 121 (2004)
  • [9] R. Sistla, V.S. Tata, Y.V. Kashyap, D. Chandrasekar, and P.V. Diwan, J. Pharm. Biomed. Anal. 39, 517 (2005)
  • [10] K. Shivshanker, N. Sreekanth, N. Harikrishnan, C. Roosewelt, P.S. Pandiyan, G.S. Rao, and V. Gunasekaran, Asian J. Chem., 19(5), 3627 (2007).
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