SPECTROPHOTOMETRIC DETERMINATION OF ROSUVASTATIN IN PURE FORM AND PHARMACEUTICAL FORMULATIONS THROUGH ION-PAIR COMPLEX FORMATION USING BROMOCRESOL GREEN
Keywords:
Direct spectrophotometric method, Rosuvastatin, Bromocresol green, Ion-pair complexAbstract
Objective: A simple, direct and accurate spectrophotometric method has been developed for the determination of rosuvastatin (RSV) in pure and pharmaceutical formulations by complex formation with bromocresol green (BCG).
Methods: The method involves the formation of a yellow ion-pair complex between rosuvastatin (RSV) and bromocresol green (BCG) reagent in chloroform.
Results: The formed complex was measured at lmax 416 nm against the reagent blank prepared in the same manner. Variables were studied in order to optimize the reaction conditions. Beer's law was obeyed in the concentration range of 0.482-24.077 μg/ml with good correlation coefficient (R2= 0.9996). The relative standard deviation did not exceed 2.8%. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.045 and 0.13 μg/ml, respectively. No interferences were caused by excipients, aspirin (ASP) and fenofibrate (FEN), but Ezetimibe (EZE), clopidogrel (CP), telmisartan (TEL), glimepiride (GLM) and diltiazem (DIL), interfere.
Conclusion: The developed method is applicable for the determination of rosuvastatin in pure and different dosage forms with an average recovery of 96.0 to 105.0% and the results are in good agreement with those obtained by the RP-HPLC reference methods.
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Mori Y, Kuriyama G, Tanaka T, Tajima N. Usefulness of aggressive lipid-lowering therapy with rosuvastatin in hypercholesterolemic patients. Endocrine 2009;3:412-8.
Nissen S, Nicholls S, Sipahi I, Libby P, Raichlen JS, Ballantyne CM. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis. Asteroid Trial JAMA 2006;295:1556-65.
Lennernas H, Fager G. Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Clin Pharmacokinet 1997;32:403-25.
Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses. Am J Cardiol 2003;92:152-60.
Diamont D, Lau KT, Brady S, Cleary J. Integration of analytical measurements and wireless communications-current issues and future strategies. Talanta 2008;75:606-12.
Ramadan AA, Mandil H, Alshelhawi N. Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using iodine and formation triiodide complex in acetonitrile. Int J Pharm Pharm Sci 2014;5:579-85.
Trivedi S, Saini P, Garg S. Oral novel spectrophotometric determination of rosuvastatin calaium in bulk and tablet dosage forms. Acta Velit 2014;1:20-4.
Rao GV, Shaiba M, Bhargavi P, Kumar TD, Swethapriya CHB. Spectrophotometric methods for the determination of rosuvastatin. Orient J Chem 2010;3:1215-7.
Prajapati P, Bodiwala K, Marolia B, Rathod I, Shah A. Development and validation of extractive spectrophotometric method for determination of rosuvastatin calcium in pharmaceutical dosage forms. J Pharm Res 2010;8:2036-8.
Krishna MV, Sankar DG. Extractive spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using safranin O and methylene blue. E-J Chem 2007;1:46-9.
Tuljarani G, Sankar DG, Kadgapathi P, Suthakaran R, Satyanarayana B. Visible spectrophotometric determination of rosuvastatin in bulk and pharmaceutical formulations. Orient J Chem 2010;2:589-93.
Ergin G, Caglar S, Onal A, Erturk toker S. Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations. Turk J Chem 2013;37:171-81.
Alzoman NZ, Sultan MA, Maher HM, Alshehri MM, Wani TA, Darwish IA. Analytical study for the charge-transfer complexes of rosuvastatin calcium with π-acceptors. Molecules 2013;18:7711-25.
Jain PS, Kale NK, Surana SJ. Quantitative estimation of rosuvastatin in bulk and tablet dosage form by using area under curve method. J Pharm Bioanal Sci 2013;4:128-33.
Gupta A, Mishra P, Shah K. Simple UV spectrophotometric determination of rosuvastatin calcium in pure form and in pharmaceutical formulations. E-J Chem 2009;1:89-92.
Rajkondwar VV, Maini1P, Vishwakarma M. Characterization and method development for estimation and validation of rosuvastatin calcium by UV–visible spectrophotometry. Int J Theor Appl Sci 2009;1:48-53.
Saha C, Sreelatha G, Nazeeruddin MA. Spectrophotometric estimation of rosuvastatin calcium in bulk and pharmaceutical formulations. Int J Pharm Anal Res 2013;3:84-8.
Lahare RY, Phuge AN, Gite AL, Jadhav AK. A review on ultraviolet spectrophotometric determination of rosuvastatin calcium in marketed formulation. Int J Pure Applied Biosci 2014;6:169-74.
Badawy AM, Mostafa NM, Abd El-Aleem Abd El-Aziz B, Lamie NT. Stability indicating spectrophotometric methods for determination of rosuvastatin in the presence of its acid degradation products by derivative spectrophotometric techniques. J Adv Pharm Res 2011;1:44-55.
Afroz A, Haque T, Talukder MU, Islam A. Spectrophotometric estimation of rosuvastatin calcium and glimepiride in tablet dosage form. Asian J Pharm Anal 2011;4:74-8.
Reddy SA, Chandrashekar KB. Development of derivative spectroscopy method for the simultaneous determination of rosuvastatin calcium and aspirin in tablet. Int J Adv Pharm Res 2012;1:706-9.
Patel DS, Shah GR, Parmar RR, Mahajan AN, Shah DA. Simultaneous estimation of rosuvastatin calcium and aspirin in pharmaceutical dosage form by UV spectrophotometric method. Int J Institutional Pharm Life Sci 2012;2:112-21.
Purkar AJ, Balap AR, Jadhav SB, Chaudhari PD. Development and validation of UV spectrophotometric method for simultaneous determination of rosuvastatin calcium and aspirin in its pure and pharmaceutical dosage forms. Int J Pharm Chem Sci 2012;3:659-63.
Vijay GD, Prajapati PB, Bodiwala KB, Shah SA. Development and validation of two spectrophotometric methods for the simultaneous estimation of rosuvastatin calcium and aspirin in their combined dosage form. Asian J Res Chem 2012;2:275-8.
Patel MJ, Panchal HJ. Simultaneous estimation of aspirin and rosuvastatin calcium in combined dosage form using derivative spectrophotometric method. Int J Pharm Prof 2012;1:540-5.
Reddy SA, Chandrasekhar KB. Development of a UV-spectrophotometric method for the simultaneous determination of rosuvastatin calcium and aspirin in tablets. J Global Trends Pharm Sci 2012;1:542-9.
Patel BB, Shah BB, Gohil KN, Patel PM. Development and validation of spectrophotometric method for simultaneous estimation of rosuvastatin calcium and aspirin in bulk and pharmaceutical dosage form. Int J Res Pharm Sci 2012;2:115-22.
Parmar V, Solanki H, Prajapati L. Derivative spectrophotometric determination of rosuvastatin calcium and fenofibrate in tablet dosage form. Pharm Anal Qual Assur 2013;2:1-5.
Rajeevkumar R, Anbazhagan S, Kumar PR, Nimesh K. Novel simultaneous determination of rosuvastatin calcium and fenofibrate in tablet formulation by derivative spectrophotometry. Int J Res Pharm Biomed Sci 2012;4:1533-8.
Sevda RR, Ravetkar AS, Shirote PJ. UV spectrophotometric estimation of rosuvastatin calcium and fenofibrate in bulk drug and dosage form using simultaneous equation method. Int J ChemTech Res 2011;2:629-35.
Mandwal PS, Patel PR, Agarwal KM, Surana SJ. Q-absorbance and multicomponent UV-spectrophotometric methods for simultaneous estimation of rosuvastatin calcium and fenofibrate in pharmaceutical formulation. Der Pharm Lett 2012;4:1054-9.
Karunakaran A, Subhash V, Chinthala R, Muthuvijayan J. Simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and in tablet dosage form by UV-spectrophotometry and RP-HPLC. Stamford J Pharm Sci 2011;1:58-63.
Patel B, Jadav A, Solanki H, Parmar S, Parmar V, Captain A. Development and validation of derivative spectroscopic method for the simultaneous estimation of rosuvastatin calcium and fenofibrate in tablet. Int J Pharma Res Rev 2013;7:1-6.
Solanki BK, Dave JB, Raval PP. Development and validation of uv spectrophotometric methods for simultaneous estimation of rosuvastatin and telmisartan in tablet dosage form. World J Pharm Pharm Sci 2014;6:2030-41.
Binal SB, Bhoomi PB, Kirtan GN, Piyush PM. Difference spectrophotometric method development and validation for simultaneous estimation of rosuvastatin calcium and telmisartan in bulk and combined dosage form. Int J Res Pharm Sci 2012;2:106-14.
Bhoomi BP, Binal S, Kirtan NG, Piyush MP. Difference spectrophotometric method development and validation for simultaneous estimation of rosuvastatin calcium and telmisartan in bulk and combined dosage form. Int J Res Pharm Sci 2012;2:115-22.
Doshi N, Sheth A, Patel T, Dave JB, Patel CN. Spectrophotometric absorption factor method development and validation for estimation of rosuvastatin calcium and telmisartan in solid dosage form. J Chem Pharm Res 2010;3:15-24.
Zalak P, Minal R. Development and validation of UV-spectrophotometric methods for simultaneous estimation of clopidogrel bisulfate and rosuvastatin calcium in bulk and formulation. Int J Adv Res 2014;2:729-34.
Anuradha GK, Vishal SD. Simultaneous UV spectrophotometric estimation of rosuvastatin and ezetimibe in their combined dosage forms. Int J Pharm Pharm Sci 2010;1:131-8.
Chaudhari BG, Patel J. Development and validation of first derivative method for simultaneous estimation of rosuvastatin and diltiazem in combined dosage form. Int J Pharm Res Scholars 2012;3:170-6.
Mehta TN, Patel AK, Kulkarni GM, Suubbaiah G. Determination of rosuvastatin in the presence of its degradation products by a stability indicating LC method. J AOAC Int 2005;4:1142-7.
Kaila HO, Ambasana MA, Thakkar RS, Saravaia HT, Shah AK. A new improved RP-HPLC method for assay of rosuvastatin calcium in tablets. Indian J Pharm Sci 2010;5:592–8.
Beludari MI, Prakash KV, Mohan GK. RP-HPLC method for simultaneous estimation of rosuvastatin and ezetimibe from their combination tablet dosage form. Int J Chem Anal Sci 2013;4:205-9.
Suslu I, Celebier M, Altnoz S. Determination of rosuvastatin in pharmaceutical formulations by capillary zone electrophoresis. Chromatographia 2007;66:65-72.
Sacide A, Banu U. Electrochemical behaviour and voltammetric determination of rosuvastatin calcium in pharmaceutical preparations using a square-wave voltammetric method. Anal Methods 2013;5:5709-16.
Ramadan AA, Mandil H, Ghazal N. Differential pulse polarographic behavior and determination of rosuvastatin in pure form and in pharmaceutical preparations using a static mercury drop electrode. Int J Pharm Pharm Sci 2015;1:389-96.
Ramadan AA, Mandil H, Ghazal N. Electrochemical behavior and differential pulse polarographic determination of rosuvastatin in pure form and in pharmaceutical preparations using dropping mercury electrode. Int J Pharm Pharm Sci 2014;3:128-33.
Sameer AM, Basavaiah AK. Spectrophotometric determination of dothiepin hydrochloride in pharmaceuticals through ion-pair complexation reaction. Chem Ind Chem Eng Q 2012;2:339−47.
Amanlou M, Keivani S, Sadri B, Gorban-Dadras O, Souri E. Simple extractive colorimetric determination of buspirone by acid-dye complexation method in solid dosage form. Res Pharm Sci 2009;1:11−8.