Application of UV-Spectrophotometry and RP-HPLC for Simultaneous Determination of Atorvastatin Calcium and Ezetimibe in Pharmaceutical Dosage Form
 
More details
Hide details
1
Department of Pharmaceutical Chemistry, R. C. Patel College of Pharmacy, Shirpur, Dist: Dhule, Maharashtra State, India 425 405
CORRESPONDING AUTHOR
Sandeep S. Sonawane   

Department of Pharmaceutical Chemistry, R. C. Patel College of Pharmacy, Shirpur, Dist: Dhule, Maharashtra State, India 425 405 Phone: +919850819154
Online publication date: 2006-06-01
Publication date: 2006-06-01
 
Eurasian J Anal Chem 2006;1(1):31–41
 
KEYWORDS
ABSTRACT
Two methods are described for the simultaneous determination of Atorvastatin calcium and Ezetimibe in binary mixture. The first method was based on UV-spectrophotometric determination of two drugs, using simultaneous equation method. It involves absorbance measurement at 232.5 nm (λmax of Ezetimibe) and 246.0 nm (λmax of Atorvastatin calcium) in methanol; linearity was obtained in the range of 5 – 25 mg.mL-1 for both the drugs. The second method was based on HPLC separation of the two drugs in reverse phase mode using Luna C18 column. Linearity was obtained in the concentration range of 8-22 mg.mL-1 for both the drugs. Both these methods have been successively applied to pharmaceutical formulation and were validated according to ICH guidelines.
 
REFERENCES (16)
1.
Moffat, A. C., Osselton, M. D. and Widdop, B., ( 2004) Clarke’s Analysis of Drugs and Poisons in Pharmaceuticals, body fluids and Postmortem material, 3 rd Edition., Part 2, The Pharmaceutical Press, Great Britain, p 654.
 
2.
Poswar, E. L., Radulovic, L. L., Cilla, D. D., Whitfield, L. R. and Sedman, A. J., Tolerance and pharmacokinetics of single-dose atorvastatin, a potent inhibitor of HMG-CoA reductase, in healthy subjects (1996) J. Clin. Pharmacol. , 36: 728.
 
3.
Page, Curtis, Sutter, Walkar and Hoffmann (2002) Integrated Pharmacology 2nd ,Mosby International Ltd., p 303.
 
4.
Altuntas, T. G. and Erk, N., Liquid chromatographic determination of Atorvastatin in bulk drugs, tablets and human plasma (2004), J. Liq. Chro. , 27 (1): 83.
 
5.
Gowari, Sankar D., Raju, M. S. M., Sumanth, Kalyan S. and Latha, P. V. M., Estimation of Atorvastatin by high performance liquid chromatography in pure and pharmaceutical dosage form (2005), Asian J. Chem, 17(4): 2571.
 
6.
McKenney, J. M., Mccormik, L. S., Weis, S., Koren, M., Kotonek, S., and Black, D. M., A Randomized Trial of the Effects of Atorvastatin and Niacin in Patients with Combined Hyperlipidemia or Isolated Hypertriglyceridemia (1998), Amer. J. Med., 104: 137.
 
7.
Black, A. E., Sinz, M. W., hayees, R. N. and Woolf, T. F., metabolism and excretion studies in mouse after single and multiple oral doses of the 3 – hydroxyl-3- methylglutaryl- CoA reductase inhibitor atorvastatin, (1998) Drug Metab. Dispos. , 26: 755.
 
8.
Bullen, W. W., Miller, R. A., Hayes, R. N., Development and validation of a high performance liquid chromatography tandem mass spectrometry assay for atorvastatin, orthohydroxy Atorvastatin and para- hydrxy Atorvastatin in human, dog and rat plasma, (1999,) Amer. Soc. Mass Spectrom. , 10: 55.
 
9.
Yadav, S. S., Mhaske, D. V., Kakad, A. B., Patil, B. D., Kadam, S. S. and Dhaneshwar, S. R., A simple and sensitive HPTLC method for the determination of content uniformity of Atorvastatin calcium tablets, (2005) Indian J. Pharm. Sci., 67(2): 182.
 
10.
Maryadele, S., Eds., In; The Merck Index, (2001) 13 th Edition, Merck and Co., Inc., Whitehouse Station, NJ, 3949.
 
11.
Heek, V. M., France, C. F., Compton, D. S., Mclead, R. I., Yunib, N. P., Alton, K, B., Sybertz, E. Z. and Davis H. R. Jr., In Vivo Metabolism-Based Discovery of a Potent Cholesterol Absorption Inhibitor, SCH58235, in the Rat and Rhesus Monkey through the Identification of the Active Metabolites of SCH48461 (1997), Pharmacol. Exp. Ther., 283, 157.
 
12.
Knopp, R., Bayes, H., Manion, C., Effect of ezetimibe on serum concentrations of lipid – soluble vitamins, (2001) Atheroscler. Suppl., 2: 90.
 
13.
Sharma, G., Kaur, K., Molecule of the month: Ezetimibe (2003), Indian J. Pharmac., 35: 406.
 
14.
Sistla, R., Tata, V. S., Kashyap, Y. V., Chandrashekhar, D and Diwan, P. V., development and validation of a reversed – phase HPLC method for the determination of Ezetimibe in pharmaceutical dosage forms, (2005), J. Pharm. Biomed. Anal., 39: 517.
 
15.
Gowari, Sankar D., Pawar, A. K. M., Kalyan, Sumnath and Latha, Madhavi P. V., Spectrophotometric determination of repaglinide and Ezetimibe , (2005), Asian J. Chem., 17(3): 2025.
 
16.
Beckett, A. H. and Stanlake, J. B., Practical Pharmaceutical Chemistry, (1997), 4 th Edition, part 2, CBS Publishers and Distributors, New Delhi (India), p 285.
 
eISSN:1306-3057