DETERMINATION OF ATORVASTATIN CALCIUM IN PURE AND ITS PHARMACEUTICAL FORMULATIONS USING IODINE IN ACETONITRILE BY UV-VISIBLE SPECTROPHOTOMETRIC METHOD

Authors

  • Abdul Aziz Ramadan Department of Chemistry, Faculty of Science, University of Aleppo, Syria
  • Hasna Mandil University of Aleppo
  • Jenan Sabouni University of Aleppo

Keywords:

Spectrophotometric method, Atorvastatin calcium (ATCa), Iodine, Triiodide complex

Abstract

Objective: A simple, sensitive and specific spectrophotometric method was developed for the determination of atorvastatin calcium (ATCa) in pure and its pharmaceutical formulations using iodine in acetonitrile.

Methods: The method is based on the oxidation of atorvastatin calcium by iodine and formation triiodide (I3−) complex.

Results: The formed complex was measured at 291 and 360 nm against the reagent blank prepared in the same manner. The optimum experimental parameters are selected. Beer's law is valid within a concentration range of 0.5586-11.173 μg/ml. The relative standard deviation did not exceed 3.0% and regression analysis showed a good correlation coefficient (R2= 0.9995). The limit of detection (LOD) and the limit of quantification (LOQ) were to be 0.056 and 0.17 μg/ml, respectively.

Conclusion: The developed method is applied for the determination of atorvastatin in pure and its commercial tablets without any interference from excipients (at lmax =291 & 360 nm), ezetimibe (EZE), fenofibrate (FEN) and aspirin (ASP) at lmax =360 nm with average recovery of 99.45 to 102.4%. The results obtained agree well with the contents stated on the labels.

 

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References

Reents S, Seymour J. Clinical Pharmacology: An Electronic Reference and Teaching Guide CD-ROM, Gold Standard Multi-media Inc., Tampa, FL; 1998.

Ramesh D, Ramakrishna S. New spectrophotometric methods for simultaneous determination of amlodipine besylate and atorvastatin calcium in tablet dosage forms. Int J Pharm Pharm Sci 2010;2:215-9.

Smita T Kumbhar, Swapnil D Jadhav, Neela M Bhatia, Manish S Bhatia. Development and validation of derivative spectrophotometric method for estimation of atorvastatin calcium and amlodipine besylate in tablet dosage form. Int J Pharm Pharm Sci 2011;3:195.

Erk N. Extractive spectrophotometric determination of atorvastatin in bulk and pharmaceutical formulations. Marcel Dekker 2003;36:2699–11.

Muthu AK, Gupta TR, Sharma S, Smith AA, Manavalan R, Kannappan N. Simultaneous estimation of amlodipine and atorvastatin in tablets using orthogonal Function ratio spectrometry. Int J Chem Sci 2008;6:2233-41.

Nagaraju P, Pasumarthy, Gopal NV, Srinivas VDN, Padma SVN. Spectrophotometric methods for the determination of atorvastatin calcium in pure and it’s pharmaceutical dosage forms. Asian J Res Chem 2008;1:64-6.

Baldha RG, Vandana BP, Bapna M. Simultaneous spectrophotometric determination of atorvastatin calcium and ezetimibe in tablet dosage form. Int J Chem Tech Res 2009;1:233-6.

Shravya A, Chandan RS, Gurupadayya BM, Sireesha M. Spectrophotometric determination of atorvastatin and ezetimibe using 2,4-dnp in bulk and pharmaceutical dosage forms. Int J Pharm Tech 2010;2:1046-56.

Patel V, Baldha R, Patel D. Simultaneous determination of atorvastatin calcium and ezetimib by ratio spectra derivative spectrophotometry and reverse phase-high performance liquid chromatography. Asian J Chem 2010;22:2511-7.

Chaudhari BG, Patel AB. Simultaneous spectrophotometric estimation of atorvastatin calcium and amlodipine besylate in tablet dosage forms. Int J Chem Tech Res 2010;2:633-9.

Wankhede SB, Dixit NR, Chitlange SS. Validated spectrophotometric methods for quantitative determination of Atorvastatin calcium and Metoprolol succinate in Capsules. Pharm Chem 2010;2:134-40.

Jadhav S, Bhatia M, Thamake S, Pishawikar S. Spectrophotometric methods for estimation of atorvastatin calcium form tablet dosage forms. Int J Pharm Tech Res 2010;2:1948-53.

Rao L, Rajeswari KR, Sankar GG. Spectrophotometric method for simultaneous estimation of atorvastatin and amlodipine in tablet dosage form. Res J Pharm Biol Chem Sci 2010;1:975-85.

Sharma S, Sharma MC. Method development and validation of atorvastatin calcium using FeCl3 by UV-visible spectrophotometric method. Am Eurasian J Toxicol Sci 2011;3:105-10.

Havele OS, Havele SS. Simultaneous determination of atorvastatin calcium and pioglitazone hydrochloride in its multicomponent dosage forms by UV spectrophotometry. Int J Pharm Pharm Sci Res 2011;1:75-9.

Sankar KAS, Vetrichelvan T, Venkappaya D. Simultaneous estimation of ramipril acetylsalicylic acid and atorvastatin calcium by chemometrics assisted UV-spectrophotometric method in capsules. Acta Pharm 2011;61:283–96.

Savithri R, Sai Sree Bindu N, Shiva Bhargavi P, Theja DHH, Ramalingam P. Dual wavelength UV-spectrophotometric method for simultaneous estimation of atorvastatin and ezetimibe in bulk and their combined tablet dosage form. Pharm Sin 2011;2:251-8.

Kumar Bada P, Kumar Sahu P, Abhinov T. Simple spectrophotometric methods for simultaneous determination of losartan potassium and atorvastatin calcium in combined dosage forms. J Chem Pharm Sci 2011;4:127-31.

Prajapati KP, Bhandari A. Spectroscopic method for estimation of atorvastatin calcium in tablet dosage form. Indo Global J Pharm Sci 2011;1:294-9.

Wani TA, Khalil NY, Abdel-Rahman HM, IA Darwish. Novel microwell-based spectrophotometric assay for determination of atorvastatin calcium in its pharmaceutical formulations. Chem Cen J 2011;5:1-8.

Frag EYZ, Mohamed GG, Gaber MH. Sensitive extractive spectrophotometric method for the determination of some statin drugs in pharmaceutical preparations. Insight Pharm Sci 2011;1:39-46.

Singh S, Inamullah, Rai J, Choudhary N, Sharma S. Stability-indicating UV-vis spectrophotometric method for estimation of atorvastatin calcium and fenofibrate in tablet dosage form. Bull Pharm Res 2012;2:159-66.

Bernard S, Mathew M. Spectrophotometric method of estimation of atorvastatin calcium using sulfo-phospho-vanillin reaction. J Appl Pharm Sci 2012;2:150-4.

Kane RN, Bhokare PS, Desai DS. Simultaneous spectrophotometric estimation of atorvastatin and fenofibrate in bulk drug and dosage form by using dual wavelength method. Int J Res Pharm Biomed Sci 2012;3:1448-53.

Dey S, Sarkar S, Malakar J, Ghosh A, Gangopadhyay A, Mazumder B. Spectrophotometric method for simultaneous determination of atenolol and atorvastatin in tablet dosage forms. Int J Pharm Biomed Res 2012;3:40-3.

Mateti A, Thimmaraju MK, Raghunandan N. Development, validation and estimation of atorvastatin calcium bulk and in its pharmaceutical formulation by spectrophotometric method. Int J Institutional Pharm Life Sci 2012;2:255-64.

Belal T, Daabees H, Abdel-Khalek M, Mahrous M, Khamis M. New simple spectrophotometric method for determination of the binary mixtures (atorvastatin calcium and ezetimibe; candesartan cilexetil and hydrochlorothiazide) in tablets. J Pharm Anal 2013;3:118–26.

Ghanty S, Sadhukhan N, Mondal A. Development and validation of a UV-spectrophotometric method for quantification of atorvastatin in tablets. J Pharm Sci Tech 2012;2:34-40.

Sakpal PH, Deodhar MN, Ghodse VP, Agarwal BA, Khiste RH, Sonawane RA, et al. Simultaneous spectrophotometric estimation of ezetimibe and atorvastatin in Pharmaceutical dosage form. Int J Chem Sci 2012;10:131-6.

Shariati-Rad M, Irandoust M, Amini T, Ahmadi F. Partial least squares and continuous wavelet transformation in Simultaneous spectrophotometric determination of amlodipin and Atorvastatine. Pharm Anal Acta 2012;3:2153-9.

Inda SS, Sharma S, Das v, kumar B, bhandari A. First derivative spectrophotometric method for the estimation of atorvastatin calcium as bulk and in tablet dosage form. Int J Pharm Pharm Sci 2013;5:530-3.

Erg˙in G, Ca˘glar S, ¨Onal A, Ert¨urk Toker S. Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations. Turkish J Chem 2013;37:171–81.

Sasikala M, Pravalika A, Bhaskar VU, Teja PH. Development and validation of UV spectrophotometric method for the simultaneous estimation of atorvastatin calcium and pioglitazone hydrochloride in tablet dosage form by derivative spectroscopic method. Int Bull Drug Res 2013;3:39-48.

Bernard S, Mathew M, Senthilkumar KL, Girija KN. Simultaneous estimation of atorvastatin calcium and amlodipine besylate by uv spectrophotometric method using hydrotropic solubilization. Hygeia: J Drugs Med 2013;5:105-12.

Rath K, Samantaray V, Dinda C. Development andvalidation of new analytical method for the estimation of atorvastatin calcium hydrate residue by using UV spectrophotometer. Int J Pharm Sci Res 2013;4:3416-24.

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;6:579-85.

Suma BV, Kannan K, Madhavan V, Chandini R. Nayar, Simultaneous estimation and validation of atorvastatin calcium and nicotinic acid in combined tablet dosage form by RP HPLC method. Int J Pharm Pharm Sci 2012;4:369-72.

Shah Y, Iqbal Z, Ahmad L, Khan A, Khan MI, Nazir S, et al. Simultaneous determination of rosuvastatin and atorvastatin in human serum using RP-HPLC/UV detection: Method development, validation and optimization of various experimental parameters. J Chromatogr B 2011;879:557-63.

Li Z, Deng YJ, Wang XM, Lei GF. HPLC determination of entrapment of coenzyme Q10. Chin J Pharm Anal 2006;26:149â€51.

Jemat Z, Ouyang BC. Determination of pharmaceuticals in aquas samples using positive and negetive voltage switching microbore liquid chromatography/electrospray ionisation tandem mass spectrometry. J Mass Spectrum 2003;38:27-34.

Guihen E, Sisk GD, Scully NM, Glennon JD. Rapid analysis of atorvastatin calcium using capillary electrophoresis and microchip electrophoresis. Electrophoresis 2006;27:2338-47.

Korany MA, Hewala II, Abdel-Hay KM. Determination of etofibrate, fenofibrate, and atorvastatin in pharmaceutical preparations and plasma using differential pulse polarographic and square wave voltammetric techniques. J AOAC Int 2008;91:1051-8.

Erk N. Development of electrochemical methods for determination of atorvastatin and analytical application to pharmaceutical products and spiked human plasma. Crit Rev Anal Chem 2004;34:1–6.

Dogan-Topal B, Uslu B, Ozkan SA. Investigation of electrochemical behavior of lipid lowering agent atorvastatin calcium in aqueous media and its determination from pharmaceutical dosage forms and biological fluids using boron-doped diamond and glassy carbon electrodes. Comb Chem High Throughput Screening 2007;10:571–82.

Dilek Eskiköy, Zehra Durmuş, Esma Kiliç. Electrochemical oxidation of atorvastatin and its adsorptive stripping determination in pharmaceutical dosage forms and biological fluids. Collect Czech Chem Commun 2011;76:1633-49.

Ramadan AA, Mandil H, Hafez B. Differential pulse polarography of atorvastatin in pure and pharmaceutical dosage forms using static mercury drop electrode. Int J Pharm Pharm Sci 2013;5:434-40.

Ramadan AA, Mandil H, Hafez B. Differential pulse polarographic determination of atorvastatin in pharmaceutical dosage forms using dropping mercury electrode. Asian J Chem 2013;25:3467-72.

Ramadan AA, Mandil H, Hafez B. Effect of hanging mercury drop electrode on differential pulse polarographic analysis of atorvastatin in pharmaceuticals using borax buffer at pH7.50. Int J Pharm Pharm Sci 2012;4(Suppl 5):540-6.

Labat P. Ph. D. Thesis, Electrochemical analysis of some toxic pollutants. Aleppo University, Aleppo, Syria; 1992.

Ramadan AA, Sabagh G. The effect of non-aqueous solvents on potentiometric titration of Cu(II) and Pb(II) by iodide and determination of pollution by copper and lead using ion selective electrodes. Res J Aleppo University 1994;17:93-12.

Edrees G. M. Sc. Thesis, High frequency titration of halogens in non-aqueous media, Aleppo University, Aleppo, Syria; 2005.

Ramadan AA, Agasyan PK, Petrov SI. Spectrophotometric and potentiometric study of formation I3-complex in mixture solvents. Gen Chem 1974;44:983-92.

Ramadan AA, Agasyan PK, Petrov SI. Spectrophotometric determination of formation constant I3-complex in some organic solvents. Gen Chem 1974;44:2299-07.

Ramadan AA, Agasyan PK, Petrov SI. Potentiometric titration of iodine by a thiosulphate solution in non-aqueous media and the formation of I3- complex ion. Zh Anal Khim 1973; 28: 2396-01.

Ramadan AA, Agasyan PK, Petrov SI. Effect of mixed solvents on determination of iodine by sodium thiosulphate solution with potentiometric detection of an end point. Zh Anal Khim 1974;29:544-50.

Ramadan AA, Ashur S. Spectophotometric determination of iodine and iodide, bromide and chloride by iodine in non-aqueous solvents and formation of polyhalogen complexes. Res J Aleppo Univ 1989;11:57-76.

Ramadan AA, Ashur S. Spectophotometric and potentiometric study of I2:Y-(Y-=I-or Br-or Cl-) complexes in non-aqueous solvents. Res J Aleppo Univ 1995;20:143-63.

Published

01-09-2015

How to Cite

Aziz Ramadan, A., H. Mandil, and J. Sabouni. “DETERMINATION OF ATORVASTATIN CALCIUM IN PURE AND ITS PHARMACEUTICAL FORMULATIONS USING IODINE IN ACETONITRILE BY UV-VISIBLE SPECTROPHOTOMETRIC METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 9, Sept. 2015, pp. 427-33, https://journals.innovareacademics.in/index.php/ijpps/article/view/7535.

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