Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations
Simple and accurate spectrophotometric methods are presented for the determination of five 3-hydroxy-3-methylglutaryl coenzyme-A (HMG-CoA) reductase inhibitors (statins), namely atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and simvastatin, in pharmaceutical preparations. The methods are based on the reaction of drugs as n-electron donor with 7,7,8,8-tetracyanoquinodimethane as p-acceptors to give highly colored complex species. All variables were studied in order to optimize the reaction conditions. Beer's law was obeyed in the concentration ranges 4--20 m g mL-1, 4--12 m g mL-1, 0.8--2.4 m g mL-1, 4--14 m g mL-1, and 2.5--20 m g mL-1 for atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and simvastatin, respectively. The proposed methods were successfully applied to the pharmaceutical preparations without any interference from excipients.
Spectrophotometric determination of 3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors in pharmaceutical preparations
Simple and accurate spectrophotometric methods are presented for the determination of five 3-hydroxy-3-methylglutaryl coenzyme-A (HMG-CoA) reductase inhibitors (statins), namely atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and simvastatin, in pharmaceutical preparations. The methods are based on the reaction of drugs as n-electron donor with 7,7,8,8-tetracyanoquinodimethane as p-acceptors to give highly colored complex species. All variables were studied in order to optimize the reaction conditions. Beer's law was obeyed in the concentration ranges 4--20 m g mL-1, 4--12 m g mL-1, 0.8--2.4 m g mL-1, 4--14 m g mL-1, and 2.5--20 m g mL-1 for atorvastatin, fluvastatin, pitavastatin, rosuvastatin, and simvastatin, respectively. The proposed methods were successfully applied to the pharmaceutical preparations without any interference from excipients.
___
- m etho d s fo r th e assa y o f d rugs (n =5 ). Tobert, J. A. Nat. Rev. Drug Discov. 2003, 2, 517–526.
- Jones, P. H.; Davidson, M. H.; Stein, E. A.; Bays, H. E.; McKenney, J. M.; Miller, E. Am. J. Cardiol. 2003, 92, 152–160.
- Caslake, M. J.; Stewart, G.; Day, S. P.; Daly, E. Atherosclerosis 2003, 171, 245–253.
- Endo, A. J. Lipid Res 1992, 33 1569–1582.
- Erturk, S.; Onal, A.; C ¸ etin, S. M. J. Chromatogr. B 2003, 793, 193–205.
- Sweetman, S. C. Martindale: The Complete Drug Reference, 34th Ed., Pharmaceutical Press, London, 2004.
- Terata, Y.; Saito, T.; Fujiwara, Y.; Hasegawa, H.; Miura, H.; Watanabe, H.; Chiba, Y.; Kibira, S.; Miura, M. Pharmacology 2003, 68, 169–176.
- Lennernas, H.; Fager, G. Clin Pharmacokinet. 1997, 32 403–425.
- Nagaraju, P.; Pasumarthy; Gopal, N. V.; Srinivas, V. D. N.; Padma, S. V. N. Asian J. Res. Chem. 2008, 1, 64–66. Erk, N. Anal. Lett. 2003, 36, 2699–2711.
- Nagaraj; Vipul K.; Rajshree, M. Anal. Sci. 2007, 23, 445–451.
- Stanisz, B.; Rafa, W. Chem. Anal-Warsaw 2008, 53, 417–428.
- Ashour, S.; Bahbouh, M.; Khateeb, M Int. J. Biomed. Sci. 2010, 6, 19–26.
- Saminathan, J.; Ksankar, A. S.; Anandakumar, K.; Vetrichelvan, T. E-J. Chem. 2009, 6, 1233–1239.
- Erk, N. Phamazie 2002, 57, 817–819.
- Moussa, B. A.; Mohamed, M. F.; Youssef, N. F. Eur. J. Chem. 2010, 1, 348–351.
- Wang, L.; Asgharnejad, M. J. Pharmaceut. Biomed. 2000, 21, 1243–1248.
- Gupta, A.; Mishra, P.; Shah, K. E-J. Chem. 2009, 6, 89–92.
- Krishna, M. V.; Sankar, D. G. E-J. Chem. 2007, 4, 272–278.
- Sankar, G. D.; Babu, J. P.; Kumar, A. B.; Krishna, V. M. Acta Cienc. Indica, Ser. Chem. 2007, 33, 1–4.
- Gomes, F.; Garcia, P.; Alves, J.; Singh, A.; Kedor-Hackmann, E.; Santoro, M. Anal. Lett. 2009, 42, 1784–1804.
- Altuntas, T. G.; Erk, N. J. Liq. Chromatogr. R. T. 2004, 27, 83–93.
- Pasha, M. K.; Muzeeb, S.; Basha, S. J. S.; Shashikumar, D.; Mullangi, R.; Srinivas, N. R. Biomed. Chromatogr. 2006 20, 282–293.
- Seshachalam, U.; Kothapally, C. B. J. Liq. Chromatogr. R. T. 2008, 31, 714–721.
- Vuletic, M.; Cindric, M.; Kouznjak, J. D. J. Pharmaceut. Biomed. 2005, 37, 715–721.
- Carlucci, G.; Mazzeo, P. J. Pharmaceut. Biomed. 1992, 10 693–697.
- Ochiai, H.; Chiyama, N. K.; Imagaki, S. J. Chromatogr. B 1997, 694, 211–217.
- Abdallah, O. M. E-J. Chem. 2011, 8(2), 753–761.
- Kaila, H. O.; Ambasana, M. A.; Thakkar, R. S.; Saravaia, H. T.; Shah, A. K. Indian J. Pharm. Sci. 2010, 72, 592–598.
- Kumar, N. S.; Nisha, N.; Nirmal, J.; Sonali, N.; Bagyalakshmi, J. Pharm. Anal. Acta 2011, 2, 1–4.
- Sane, R. T.; Kamat, S. S.; Menon, S. N.; Inamdar, S. R.; Mote, M. R. J. Planar Chromatogr. -Mod. TLC 2005, 18, 194–198.
- Yadav, S.; Mhaske, D.; Kakad, A.; Patil, B.; Kadam, S.; Dhaneshwar, S. Indian J. Pharm. Sci. 2005, 67, 182–186. Erk, N. Crit. Rev. Anal. Chem. 2004, 34, 1–7.
- Dogan-Topal, B.; Uslu, B.; ¨ Ozkan, S. A. Comb. Chem. High T. Scr. 2007, 10, 571–582.
- Saleh, G. A. Talanta 1998, 46, 111–121.
- Kovar, K. A.; Abdel-Hamid, M. E. Arch. Pharm. 1984, 317, 246–250.
- Foster, R. Organic Charge-Transfer Complexes, Academic Press, London, 1969.
- Melby, L. R.; Patai, S. The Chemistry of the Cyano Group, Interscience, New York, 1970.
- Rao, C. N. R.; Bhat, S. N.; Dwivedi, P. C. Applied Spectroscopy Reviews, 5, Brame, E.D., ed, Marcel Dekker, New York, 1972.
- Kovar, K. A.; Mayer, W.; Auterhoff, H. Arch. Pharm. 1981, 314, 447–458.
- Abdellatef, H. E. J. Pharmaceut. Biomed. 1998, 17, 1267–1271.
- Saleh, G. A.; Askal, H. F.; Darwish, L. A.; El-Shorbagi, A. N. A. Anal. Sci. 2003, 19, 281-287.
- Abdel-Gawad, F. M.; Issa, Y. M.; Fahmy, H. M.; Hussein, H. M. Microchim. Acta 1998, 130, 35–40.
- Hussein, S. A.; Mohamed, A. M.; Abdel-Alim, M. Analyst 1989, 114, 1129–1131.
- Job, P. Anal. Chem. 1928, 9, 113–203.
- ICH, Q2 (R1), Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, 2005.
- United States Pharmacopoeia National Formulary, USP 30-NF 25, United States Pharmacopoeia Convention Inc., Rockville, Maryland, USA; 2007.
- United States Pharmacopoeia National Formulary, USP 32-NF 27, United States Pharmacopoeia Convention Inc., Rockville, Maryland, USA; 2009.