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.
References
[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.

 
 
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