Simultaneous determination of strontium ranelate and aspartame in pharmaceutical formulation for the treatment of postmenopausal osteoporosis by capillary zone electrophoresis

Microchemical Journal

Volumn 117, Issue , 2014, Pages 214-219

  Corrêa de Carvalho, Renata ^a   Pereira Netto, Annibal Duarte ^a   Marques, Flávia Ferreira de Carvalho ^a,b  

^a FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

^b FLUMINENSE FEDERAL UNIVERSITY   (Brazil)

Author keywords

Aspartame; Capillary electrophoresis; Capillary zone electrophoresis; Osteoporosis; Strontium ranelate

Indexed keywords

EID: 84904395454     PISSN: 0026265X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.microc.2014.06.024     Document Type: Article

References (35)

1. Lane N.E. Epidemiology, etiology, and diagnosis of osteoporosis. Am. J. Obstet. Gynecol. 2006, 194:S3-S11.
2. Bonnelye E., Chabadel A., Saltel F., Jurdic P. Dual effect of strontium ranelate: stimulation of osteoblast differentiation and inhibition of osteoclast formation and resorption in vitro. Bone 2008, 42:129-138.
3. Khajuria D.K., Razdan R., Mahapatra D.R. Medicamentos para o tratamento da osteoporose: revisão. Rev. Bras. Reumatol. 2011, 51(4):365-382.
4. Roux S. New treatment targets in osteoporosis. Joint Bone Spine 2010, 77:222-228.
5. Cauley J.A., Robbins J., Chen Z., Cummings S.R., Jackson R.D., LaCroix A.Z., LeBoff M., Lewis C.E., McGowan J., Neuner J., Pettinger M., Stefanick M.L., Wactawski-Wende J., Watts N.B. Effects of estrogen plus progestin on risk of fracture and bone mineral density. JAMA 2003, 290(13):1729-1738.
6. Sambrook P.N., Ebeling P. Osteonecrosis of the jaw. Curr. Rheumatol. Rep. 2008, 10:97-101.
7. European Medicines Agency (EMA) Protelos: European public assessment reports. Product Information 2009.
8. Swami A.S., Pishawikar S.A., More H.N. Forced degradation study of strontium ranelate (anti-osteoporotic drug). Int. J. Pharm. Sci. Rev. Res. 2012, 12(2):22-26.
9. Barbara A., Delannoy P., Denis B.G., Marie P.J. Normal matrix mineralization induced by strontium ranelate in MC3T3-E1 osteogenic cells. Metabolism 2004, 53(4):532-537.
10. Baron R., Tsouderos Y. In vitro effects of S12911-2 on osteoclast function and bone marrow macrophage differentiation. Eur. J. Pharmacol. 2002, 450:11-17.
11. Canalis E., Hott M., Deloffre P., Tsouderos Y., Marie P.J. The divalent strontium salt S12911 enhances bone cell replication and bone formation in vitro. Bone 1996, 18(6):517-523.
12. Takahashi N., Sasaki T., Tsouderos Y., Suda T. S 12911-2 inhibits osteoclastic bone resorption in vitro. J. Bone Miner. Res. 2003, 18(6):1082-1087.
13. Marie P.J., Hott M., Modrowski D., Pollak C., Guillemain J., Deloffre P., Tsouderos Y. An uncoupling agent containing strontium prevents bone loss by depressing bone resorption and maintaining bone formation in estrogen-deficient rats. J. Bone Miner. Res. 1993, 8(5):607-615.
14. Sabah S., Scriba G.K.E. Determination of aspartame and its degradation and epimerization products by capillary electrophoresis. J. Pharm. Biomed. Anal. 1998, 16:1089-1096.
15. Soffritti M., Belpoggi F., Esposti D.D., Lambertini L. Aspartame induces lymphomas and leukaemias in rats. Eur. J. Oncol. 2005, 10(2):107-116.
16. Schernhammer E.S., Bertrand K.A., Birmann B.M., Sampson L., Willett W.W., Feskanich D. Consumption of artificial sweetener-and sugar-containing soda and risk of lymphoma and leukemia in men and women, Am J Clin Nutr 2012, 10.3945/ajcn.111.030833.
17. WHO Twenty-fifth Report of the Joint/FAO/WHO Expert Committee on Food Additives: Evaluation of Certain Food Additives, Geneva 1981.
18. Food U.S., Administration Drug (access date: October 2013). http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfiMedicine/.
19. Mythili K., Gayatri S., Teja K.R., Chitra K., Reddy C.U.M. Development and validation of RP-HPLC method for the estimation of strontium ranelate in sachet. Int. J. Pharma Bio. Sci. 2011, 2(2):258-263.
20. Swami A.S., Pishawikar S.A., More H.N. UV-Spectrophotometric method development and validation for estimation of strontium ranelate in bulk. Int. J. Pharma Bio Sci. 2012, 3(4):171-176.
21. Altria K.D., Kelly M.A., Clark B.J. Current applications in the analysis of pharmaceuticals by capillary electrophoresis. Trends Anal. Chem. 1998, 17(4):204-214.
22. Alnajjar A., AbuSeada H.H., Idris A.M. Capillary electrophoresis for the determination of norfloxacin and tinidazole in pharmaceuticals with multi-response optimization. Talanta 2007, 72:842-846.
23. Herndndez M., Borrull F., Calull M. Capillary zone electrophoresis determination of oxytetracycline in pig tissue samples at maximum residue limits. Chromatographia 2001, 54:355-359.
24. Tavares M.F.M. Mecanismos de separação em eletroforese capilar. Quim. Nova 1997, 20(5):493-511.
25. Frazier R.A., Ames J.M., Nursten H.E. Capillary Electrophoresis for Food Analysis Method Development 2000, Ellis Horwood PTR Prentice Hall, Cambridge, UK.
26. García-Jiménez J.F., Valencia M.C., Capitán-Vallvey L.F. Improved multianalyte determination of the intense sweeteners aspartame and acesulfame-K with a solid sensing zone implemented in an FIA scheme. Anal. Lett. 2006, 39:1333-1347.
27. European Medicines Agency (EMA) (acess date: November 2013). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000560/WC500131790.pdf.
28. Hsieh T.-J., Chen S. A facile HPLC method for optical purity and quantitative measurements of phenylalanine from the hydrolyzed aspartame under different pH and temperature after its derivatization with a fluorescent reagent. Amino Acids 2007, 33:123-128.
29. Berset J.-D., Ochsenbein N. Stability considerations of aspartame in the direct analysis of artificial sweeteners in water samples using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Chemosphere 2012, 88:563-569.
30. (Acessed in 19th of December, 2013). http://www.pharmacopeia.cn/v29240/usp29nf24s0_c727.html.
31. Hayes M.A., Ewing A.G. Electroosmotic flow control and monitoring with an applied radial voltage for capillary zone electrophoresis. Anal. Chem. 1992, 64:512-516.
32. International Conference on Harmonisation (ICH) Validation of Analytical Procedures: Text and Metodology Q2 (R1) 2005.
33. Brazilian National Agency for Sanitary Vigilance Resolution No. 899, Guide for Validation of Analytical and Bioanalytical Methods, Brazil 2003.
34. Miller J.C., Miller J.N. Statistics for Analytical Chemistry 1993, Ellis Horwood PTR Prentice Hall, Chichester, UK. third ed.
35. National Institute of Metrology, Quality and Technology (INMETRO) Guidance on Validation of Analytical Methods 2010, DOQ-CGCRE-008, Brazil.