Rodríguez CJE, López AM

Language: Spanish
References: 15
Page: 13-22
PDF size: 142.26 Kb.

ABSTRACT

Introduction: raloxifene is a selective estrogen receptor modulator from the benzothiophene family. The results of several large clinical trials have shown that raloxifene reduces the rate of bone loss in the dorsal spine and may increase bone mass at certain sites.
Objective: to validate an analytical method for determination of raloxifene in a Cuban formulation.
Methods: a high performance liquid chromatography analytical method has been developed for the estimation of raloxifene in Cuban pharmaceutical dosage form. In this method, RP 18 Lichrospher^® 100 column with mobile phase consisting of methanol, de-ionized water and trietanolamine (ratio of 70:30:0.1) and 286 nm wavelength ultraviolet detector were used. The mobile phase flow was 1.5 mL/min and the injected volume reached 20 mL.
Results: the results showed that the suggested method for raloxifene quantitation was specific, accurate, precise and linear.
Conclusions: under the studied conditions the analytic procedures can be applied for routine quality control analysis of raloxifene in pharmaceutical dosage form.

REFERENCES

1. Delmas PD, Bjarnason NH, Mitlak BH. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997;337:1641-7.

2. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999;282(7):637-45.

3. Lippman ME, Krueger KA, Eckert S, Sashegyi A, Walls EL, Jamal S, et al. Indicators of lifetime estrogen exposure: effect on breast cancer incidence and interaction with raloxifene therapy in the multiple outcomes of raloxifene evaluation study participants. J Clin Oncol. 2001;19(12):3111-6.

4. D'Amelio P, Muratore M, Tinelli F, Tamone C, Cosentino L, Quarta E, et al. Effect of raloxifene and clodronate on bone density in postmenopausal osteoporotic women. Int J Tissue React. 2003;25(2):73-8.

5. Weinstein RS, Parfitt AM, Marcus R, Greenwald M, Crans G, Muchmore DB. Effects of raloxifene, hormone replacement therapy, and placebo on bone turnover in postmenopausal women. Osteoporos Int. 2003;14(10):814-22.

6. Heringa M. Review on raloxifene: profile of a selective estrogen receptor modulator. Int J Clin Pharmacol Ther. 2003;41(8):331-45.

7. Basavarah K, Tharpa K, Rangachar U, Rajedraprasad N, Ganeshbahat S, Basavaiah K. Optimized and validated spectrophotometric methods for the determination of raloxifene in pharmaceuticals using permanganate. Arch Pharmacol Res. 2009;32(9):1271-9.

8. Pavithra DC, Lakshmi S. RP-HPLC estimation of raloxifene HCl in tablets. Indian J Pharm Sci. 2006;68:401-2.

9. Shabir GA. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International conference on Harmonization. J Chromatogr A. 2003;987:57-66.

10. Trontelj J, Tomaz V, Bogataj M, Mrhar A. HPLC analysis of raloxifene hydrochloride and its application to drug quality control studies. Pharm Res. 2005;52:334-9.

11. Pérez Ruiz T, Martinez Lozano C, Sanz A, Bravo E. Development and validation of a quantitative assay for raloxifene by capillary electrophoresis. J Pharm Biomed Anal. 2004;34(5):891-7.

12. United States Pharmacopoeia. USP 31. Washington DC.: United Pharmacopoeial Convention, Inc.; 2008. p. 752-7.

13. Chung Chow C. Analitycal method validation and instrument performance verification. Cap. 2. New Jersey: Ed. Wiley Interscience Sons; 2004. p. 11-26.

14. CECMED. Regulación No. 41. Validación de métodos analíticos. La Habana: CECMED; 2007.

15. Srinivas G, Kanumula G, Madhavan P, Kishore Kumar K, Rama Koti Reddy Y, Vishnu Priya M, et al. Development and validation of stability indicating method for the quantitative determination of Raloxifene hydrochloride and its related impurities using UPLC. J Chem Pharm Res. 2011;3(1):553-62.