ABB  Vol.1 No.2 , June 2010
Development and validation of HPTLC method for niacin and simvastatin in binary combination
Abstract: A simple, sensitive and validated HPTLC method has been developed to determine Niacin and simvastatin simultaneously in synthetic mixture form. Chromatographic separation was achieved on a RP18 plate using a mixture of Methanol: Water: Acetic acid (60:40:0.1) at a wavelength of 237 nm. Linearity of themethod was found to be in the concentration range of 5000.0-25000.0 μg/ml for niacin and 100.0-500.0 μg/ml for simvastatin with correlation coefficient greater than 0.999. The method can be used for simultaneous determination of Niacin and Simvastatin.
Cite this paper: Tiwari, P. and Sathe, P. (2010) Development and validation of HPTLC method for niacin and simvastatin in binary combination. Advances in Bioscience and Biotechnology, 1, 131-135. doi: 10.4236/abb.2010.12018.

[1]   Susman (1995) Niacin reduces triglycerides, increases good cholesterol in diabetics. Doctors Guide Publishing Limited.

[2]   Kumar, V. and Shah, R.P., (2008) LC and LC–MS methods for the investigation of polypills for the treatment of cardiovascular diseases: Part 1. Separation of active components and classification of their interaction/degradation products. Saranjit Singh Journal of Pharmaceutical and Biomedical Analysis, 47(3), 508-515.

[3]   Chaudhari, B.G., Patel, N.M., Shah, P.B. and Modi, K.P. (2006) Development and validation of a HPTLC method for the simultaneous estimation of atorvastatin calcium and ezetimibe. Indian Journal of pharamaceutical Science, 68(6), 793-796.

[4]   Jain, N. and Raghuwanshi, R. (2008) Development and validation of RP-HPTLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. Deepti Jain Indian Journal of pharmaceutical Science, 70(2), 263-265.

[5]   Kova´, L.N. and Atı´nsky´, D.S., (2008) HPLC methods for the determination of simvastatin and atorvastatin. PetrSolich Trac Trends in Analytical Chemistry, 27(4), 352-367.

[6]   Jemal, M., Ouyang, Z. and Powell, M.L.(2000) A strategy for a post-method-validation use of incurred biological samples for establishing the acceptability of a liquid chromatography/tandem mass-spectrometric method for quantitation of drugs in biological samples. Journal Pharm Biomed Anal, 16(16), 1538-1547.

[7]   Zhang, N., Yang, A., Rogers, J.D. and Zhao, J.J. (2004) Journal Pharm Biomed Anal, 34, 175-187.

[8]   Nirogi, R., Mudigonda, K. and Kandikere, V. (2004) Chromatography–mass spectrometry methods for the quantitation of statins in biological samples. Journal of pharmaceutical and Biomedical Analysis. 44, 379-387.

[9]   Research & Development report, may 2000, Australian Government Analytical Laboratories.

[10]   Khor, S.-C. and Tee, E.-S. (1996) Development of a HPLC method for the simultaneous determination of several b-vitamins and ascorbic acid. Malaysian Journal of Nutrition, 2(1), 49-65.

[11]   Euro Fir guidelines for assessment of Methods of Analysis KellieWindahi, V Craige Trenerry and Caroline Ward.

[12]   Pfuhl, P., Karcher, U., Haring, N., Baumeister, A., Tawab, M.A. and Schubert-Zsilaveez, M. (2005) Simultaneous Determination of Niacin, Niacinamide and Nicotinuric Acid in Human Plasma. Journal of Pharmaceutical and Biomedical Analysis, 36(5), 1045-1052.

[13]   Todd, P.A. and Goa, K.L., (1990) Simvastatin: A review of its pharmacological properties and therapeutic potential in hyperlipidaemia. Drugs, 40(4), 583-607.

[14]   Pasternak, R.C., Smith, S.C.J., Merz, C.N.B., Grundy, S.M., Cleeman, J.I. and Lenfant, C. (2002) ACC/ AHA/ NHLBI clinical advisory on the use and safety of statins. Journal Of The American Heart Association, 40, 567-572.

[15]   Dave, T. and Diab, E. Analysis of Simvastatin Tablets by High Speed LC. Application Notes 405, Thermo Fisher Scientific, San Jose, 1-6.

[16]   Ashfaq, M., Khan, I.U., Quatab, S.S. and Razz, S.N. (2007) Hplc determination of ezetimibe and simvastatin in pharmaceutical formulations. Journal of the Chilean Chemical Society, 52(3), 1220-1224.

[17]   Ashfaq, M., Khan, I.U. and Asghar, M.N. (2008) Development and Validation of Liquid Chromatographic Method for Gemfibrozil and Simvastatin in Binary Combination. Journal of the Chilean Chemical Society, 53(3), 1617-1619.

[18]   Yang, H., Feng, Y. and Luana, Y. (2003) Determination of Simvastatin in human plasma by liquid chromatography–mass spectrometry. Journal of Chromatography B, 785(2) 369-375.

[19]   Basavaiah, K. and Tharpa, K. (2008) The development and validation of visible spectrophotometric methods for simvastatin determination in pure and the tablet dosage forms. Chemical Industry and Chemical Engineering Quarterly, 14(3), 205-210.

[20]   Brown, G.B., Zhao, X.-Q., Chait, A., Fisher, L.D., Cheung, M.C., Morese, J.S., Dowdy, A.A., Marino, E.K., Bolson, E.L., Alaupovic, P., Frohlich, J. and Albers, J.J. (2001) Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. The New England Journal of Medicine, 345(22), 1583-1592.

[21]   Riordan, M.O. and Waknine, Y. (2008) FDA approves combination niacin and simvastatin. Medical News, Medscape.

[22]   I.C.H (Q2A) (1994) Note for guidance on validation of analytical methods, definition and terminology. International Conference on Harmonization, Human Medicines Evaluation Unit, the European Agency for the Evaluation of Medicinal Products.