Analytical Review on Raloxifene -An Estrogen Receptor Modulator in Different Pharmaceutical Formulations and Biological Fluids
Home >
2017,
Vol. 5 No. 1 > Analytical Review on Raloxifene -An Estrogen Receptor Modulator in Different Pharmaceutical Formulations and Biological Fluids
Authors
- Ashwini v. GujarDepartment of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical education and Research, Shirpur, Dist. Dhule – 425405, India
- Anand B. MundadaDepartment of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical education and Research, Shirpur, Dist. Dhule – 425405, India
- Atul A. ShirkhedkarDepartment of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical education and Research, Shirpur, Dist. Dhule – 425405, India
Keywords
Analytical Method, Raloxifene, RP-HPLC, HPTLC, Validation
Abstract
Raloxifene (RLX) is an oral selective estrogen receptor modulator (SERM). It is showing estrogenic action on bone and anti-estrogenic action on uterus and breast. An extensive literature has been published for analysis of RLX in different pharmaceutical formulations. This review article endeavor to provide the detail account on analytical methods for RLX and also validation details for its readers. It further helps to avoid costly chemicals and time consuming exercises for further investigation of RLX.
References
- Muchmore, D.B., (2000). Raloxifene: a selective estrogen receptor modulator (SERM) with multiple target system effects. The Oncologist, 5(5), 388–392. https://doi.org/10.1634/theoncologist.5-5-388
- Tripathi, K.D., (2013). Essentials of medical pharmacology. JP Medical Ltd. https://doi.org/10.5005/jp/books/12256
- Pathuri, R., Muthukumaran, M., Krishnamoorthy, B. and Nishat, A., et al. (2013). A Review on Analytical Method Development and Validation of Pharmaceutical Technology. Current Pharma Research, 3(2), 855.
- Connors, K. A., (1999). Liquid Chromatography- A Textbook of Pharmaceutical Analysis. New York: Willey Inter science.
- Backett, A. H., Stenlake, J. B. (1997) Practical Pharmaceutical Chemistry. 4thedn., Part II, CBS Publications and Distributors.
- Pharmacopoeia, (2014). Government of India Ministry of Health & Family Welfare The Controller & Publication. Delhi, India.
- Kalyanaramu, B., Raghubabu, K., Vamsi Kumar, Y. and JagannadhaRao, V., 2011. A novel method for estimation of raloxifene hydrochloride in bulk and pharmaceutical preparations by visible spectrophotometry. Der PharmaChemica, 3(2), 250–256.
- Kalyanaramu, B. and Raghubabu, K., 2011. Development of new analytical method for determination of raloxifene hydrochloride in formulations based on charge-transfer complex formation. Int J Anal Bioanal Chem, 1(2), 29–33.
- Dhumal Dinesh, PayalHasmukhlalPatil, Sanjaykumar Bari 2012 Quantitative determination of raloxifene hydrochloride in bulk and tablet formulation by UV-spectrophotometry and first order derivative using area under cuvrve method Ind Drugs 49(09)
- Nagaraju PT, K VenuGopal, Murali Krishna NV*, Bhargavi V, and Srinivasulu N 2014 UV-Spectrophotometric Method Development and Validation for Determination of Raloxifene in Pharmaceutical Dosage Form rrjpa
- Basavaiah, K., Anil Kumar, U.R., Tharpa, K. and Vinay, K.B., 2008. Validated spectrophotometric methods for the determination of raloxifene hydrochloride in pharmaceuticals. Journal of the Chilean Chemical Society, 53(3), 1635–1639. https://doi.org/10.4067/S0717-97072008000300020
- Kalyanaramu, B. and Raghubabu, K., 2011. Determination of raloxifene hydrochloride by oxidative coupling reaction in pharmaceutical formulations. Int. J. Appl. Pharm, 3, 6–9.
- Basavaiah, K. and Kumar, U.R., 2006. New sensitive spectrophotometric methods for the determination of raloxifene hydrochloride in pharmaceuticals using bromate-bromide, methyl orange and indigo carmine. Journal of Chemistry, 3(4), 242–249. https://doi.org/10.1155/2006/472186
- Kalyanaramu, B. and Raghubabu, K., 2011. A quantitative assay for raloxifene hydrochloride in bulk and pharmaceutical preparations by visible spectrophotometry. J. Chem. Pharm. Res, 3(1), 122–127.
- Salazar, F.R., Codevilla, C.F., Meneghini, L. and Bergold, A.M., 2015. Development of alternative methods for the determination of raloxifene hydrochloride in tablet dosage form. Brazilian Journal of Pharmaceutical Sciences, 51(2), 349–360. https://doi.org/10.1590/S1984-82502015000200012
- Kalyanaramu, B., Raghubabu, K., Vamsi Kumar, Y. and JagannadhaRao, V., 2011. A novel method for estimation of raloxifene hydrochloride in bulk and pharmaceutical preparations by visible spectrophotometry. Der PharmaChemica, 3(2), 250–256.
- Annapurna, M., Rao, E and Kumar, B.V.V., (2007). Spectrophotometric determination of raloxifene hydrochloride in pharmaceutical formulations.Journal of Chemistry, 4(1), 79–82. https://doi.org/10.1155/2007/480625
- Moussa, A., El-Bagary, I and Osman, E.E.A., (2013). Optimized Spectrophotometric Methods for the Determination of Raloxifene Hydrochloride. International Research Journal of Pure and Applied Chemistry, 3(3), 220. https://doi.org/10.9734/IRJPAC/2014/4588
- Pavithra, C and Lakshmi S., (2006). New Spectrophotometric Determination of Raloxifene Hydrochloride in Tablets. Indian Journal of Pharmaceutical Sciences, 68, 3.
- Basavaiah K., Tharpa K., Anil Kumar R., Rajedraprasad N., HiriyannaSg., Vinay, B., (2009). Optimized and validated spectrophotometric methods for the determination of raloxifene in pharmaceuticals using permanganate. Arch Pharm Res., 32(9), 1271–1279. https://doi.org/10.1007/s12272-009-1913-7
- Moussa, A., El-Bagary, I and Osman, E.E.A., (2013). Spectrophotometric and Chromatographic Methods for the Estimation of Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulations. American Chemical Science Journal, 3(4), 378–386. https://doi.org/10.9734/ACSJ/2013/4598
- Sathyaraj, A., Satyanarayana, V. and Basaveswara, R., 2011. Gradient RP-HPLC method for the determination of Purity and Assay of Raloxifenehydrochloride in Bulk Drug. Research Journal of Chemical Sciences, 1(2), 9–16.
- Reddy, P.V., Rani, B.S., Babu, G.S. and Rao, J.V.L.N., 2006. RP-HPLC determination of Raloxifene in pharmaceuticl tablets. Journal of Chemistry, 3(1), 60–64. https://doi.org/10.1155/2006/713569
- Pulla Reddy, S., Vardhan, S.V.M., Ravi Kumar, D., Shanmukha Kumar, J.V. and Rambabu, C., 2012. Development and Validation of RP-HPLC Method for the Estimation of Raloxifene in Marketed Formulations. Analytical Chemistry Letters, 2(6), 358–362. https://doi.org/10.1080/22297928.2012.10662620
- Kumar, B.V., Kumar, K.P., Suresh, K., Aspar, S., Srikanth, P. and Suneetha, Y., 2011. Development and validation of RP-HPLC method for determination of raloxifene hydrochloride from pharmaceutical preparation. J Chem Pharm Res, 3(3), 784–91.
- Sandeep K*, Vijaykumar N, Mohanvarma M and Veerabhadraswamy P 2013 Development and validation of a dissolution method for Raloxifene hydrochloride in pharmaceutical dosage forms using RP-HPLC J Chem Pharm Res, 5(12), 981–987
- Madhu, B., Kumara, A.A., Prashanth, S., Kumar, Y., Pradeep, R.J. and Ramesh, G., 2011. Sensitive and rapid HPLC method for the determination of raloxifene hydrochloride. Journal of Pharmacy Research, 4(3), 582–584.
- Trontelj, J., Vovk, T., Bogataj, M. and Mrhar, A., 2005. HPLC analysis of raloxifene hydrochloride and its application to drug quality control studies. Pharmacological research, 52(4), 334–339. https://doi.org/10.1016/j.phrs.2005.05.007
- Mishra, R., Matkar, S., Malvia, H. and Khan, M.A., 2014. Development and Validation of a High-Performance Liquid Chromatographic Method for Related Substances of Raloxifene Hydrochloride in Bulk and Pharmaceutical Formulations. Trends in Drug Delivery, 1(1), 16–23.
- Basavaiah, K., Anil Kumar, U. and Tharpa, K., 2008. Gradient HPLC analysis of raloxifene hydrochloride and its application to drug quality control. Actapharmaceutica, 58(3), 347–356. https://doi.org/10.2478/v10007-008-0018-z
- Suneetha, D. and Rao, A.L., 2010. A new validated RP-HPLC method for the estimation of raloxifene in pure and tablet dosage form. Rasayan Journal of Chemistry, 3 (1), 117–121.
- Salazar, F.R., Codevilla, C.F., Meneghini, L. and Bergold, A.M., 2015. Development of alternative methods for the determination of raloxifene hydrochloride in tablet dosage form. Brazilian Journal of Pharmaceutical Sciences, 51(2), 349–360. https://doi.org/10.1590/S1984-82502015000200012
- Pavithra, D.C. and Sivasubramanian, L., 2006. RP-HPLC estimation of raloxifene hydrochloride in tablets. Indian journal of pharmaceutical sciences, 68(3), 401–402 https://doi.org/10.4103/0250-474X.26660
- Farmer, S., Anderson, P., Burns, P., and Velagaleti, R., (2002). Forced Degradation of Ibuprofen in Bulk Drugs and Tablets. Pharmaceutical Technology 28(42), 13.
- Bhat, P. and Velingkar, VS., (2004). Synthesis and Characterization of Degradation Products in Diclofenac-Na and Clotrimazole. Indian Drugs, 40 (7): 396.
- Volk, KJ., Hill, SE., Kerns, EH., Lee MS., (1997). Profiling degradants of paclitaxel using liquid chromatography-mass spectrometry and liquid chromatography-tandem mass spectrometry
- substructural techniques. J Chromatogr B, 696(1), 99. https://doi.org/10.1016/S0378-4347(97)00208-9
- European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare, 2010. European pharmacopoeia. Renouf Publishing Company Limited. 7.0, 284.2–2843.
- USP-NF27. Pharmacopeial Forum. 33(4), 673.
- Jančić-Stojanović, B., Rakić, T., Kostić, N., Vemić, A., Malenović, A., Ivanović, D. and Medenica, M., (2011). Advancement in optimization tactic achieved by newly developed chromatographic response function: application to LC separation of raloxifene and its impurities. Talanta, 85(3), 1453 1460. https://doi.org/10.1016/j.talanta.2011.06.029
- Jagadeesh, N., Kumara, Y.R., Jayashreeb, A. and Mohantya, S., (2014). Structural Elucidation of Potential Impurities of Raloxifene Hydrochloride by LC/ESI-MS and NMR. Journal of Pharmacy Research, 8(6), 718–727.
- Reddy, BR., Goud, VT., Nagamani, n., Pavankumar, n., Alagudurai, A., Murugan, R., Parthasarathy, K., Karthikeyan, V. and Balaji, P., (2012). Identification and characterization of potential impurities in raloxifene hydrochloride. Scientia pharmaceutica, 80(3), 605–618. https://doi.org/10.3797/scipharm.1204-13
- Chen, T.T., Huang, T.Y., Pan, R.N., Chang-Chien, G.P. and Hsu, M.C., (2013). Determination of Raloxifene in Urine by Liquid Chromatography-Tandem Mass Spectrometry for Doping. Journal of analytical toxicology, 37(6), 345–350. https://doi.org/10.1093/jat/bkt041
- Krishna, D., Dr. Tushar, M.,LC-MS/MS Method for the Determination of Raloxifene and its Glucuronide Metabolites from Human Plasma Using SPE Micro Elution. Thermo scientific, 1–8.
- Kang, J., Hwang, H., Lee, W. and Kim, H., (2007). Validation and application of a screening method for β2-agonists, anti-estrogenic substances and mesocarb in human urine using liquid chromatography/tandem mass spectrometry. Rapid communications in mass spectrometry, 21(2), 252–264. https://doi.org/10.1002/rcm.2834
- Trdan, T., Roškar, R., Trontelj, J., Ravnikar, M. and Mrhar, A., (2011). Determination of raloxifene and its glucuronides in human urine by liquid chromatography–tandem mass spectrometry assay. Journal of Chromatography B, 879(23), 2323–2331. https://doi.org/10.1016/j.jchromb.2011.06.031
- Jurij, T., Marija, B., Janja, M., Aleˇs, M., (2007).Development and validation of a liquid chromatography–tandem mass spectrometry assay for determination of raloxifene and its metabolites in human plasma. Journal of Chromatography B, 855(2), 220–227. https://doi.org/10.1016/j.jchromb.2007.05.004
- Perez-Ruiz, T., Martı́nez-Lozano, C., Sanz, A. and Bravo, E., (2004). Development and validation of a quantitative assay for raloxifene by capillary electrophoresis. Journal of pharmaceutical and biomedical analysis, 34(5), 891-897. https://doi.org/10.1016/j.jpba.2003.12.008
- Sowjanya, G., Annapurna, M. and RAO, S., (2012). Validated stability-indicating liquid chromatographic method for the determination of raloxifene (anti-osteoporotic agent) in tablets. Journal of Drug Delivery and Therapeutics, 2(4), 4. https://doi.org/10.22270/jddt.v2i4.257
- Rajasekaran, A., Preethi, N., Arivukkarasu, R.,(2014). Stability indicating High Performance Thin Layer Chromatographic determination of Raloxifene Hydrochloride. Pharma Research Library, 2(2), 348–355.
- Shirkhedkar, A., Rajput, K., Rajput, K. and Surana, S.J., (2012). Stability-Indicating RP-TLC/Densitometry Determination of Raloxifene Hydrochloride in Bulk Material and in Tablets. Chromatography Research International, 2012, 1–7. https://doi.org/10.1155/2012/356216
- Merey, A., Galal, M., Salem, Y. and Abdel-Moety, M., (2013). Novel stability indicating methods for the determination of certain synthetic estrogen level modifiers. Bulletin of Faculty of Pharmacy, Cairo University, 51(1), 69–79. https://doi.org/10.1016/j.bfopcu.2012.11.001
How to Cite
Ashwini v. Gujar, Anand B. Mundada, Atul A. Shirkhedkar. Analytical Review on Raloxifene -An Estrogen Receptor Modulator in Different Pharmaceutical Formulations and Biological Fluids.
J. Pharm. Technol. Res. Manag.. 2017, 05, 51-57
