ESTIMATION OF ELETRIPTAN HYDROBROMIDE IN ORAL FILM DOSAGE FORM BY RP-HPLC
Abstract
A simple, precise, rapid and accurate RP-HPLC method was developed for the percentage drug release estimation of Eletriptan Hydrobromide in oral film dosage form. Eletriptan Hydrobromide is used to treat severe migraine headaches and it’s associated to nausea and sensitivity to light. Eletriptan Hydrobromide oral films were prepared by solvent casting method. It is available in market as conventional tablets (Relpax). An Xterra RP18 (150 × 4.6 with 5 microns particle size) and the mobile phase, consisting of KH2PO4 and triethylamine in water adjusting the pH-7.0 with o-phosphoric acid: acetonitrile in ratio of 98:2 v/v & acetonitrile: methanol HPLC Grade (80:20 v/v) was used as mobile phase in isocratic mode. The flow rate was 1.0 mL/min and the effluents were monitored at 225 nm. The retention time was 7.0 minutes and the detector response was linear in the concentration of 6.60-99.02µg/mL for Eletriptan Hydrobromide. The respective linear regression equation being Y = 11447 X + 5508 for Eletriptan Hydrobromide. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were not applicable for dissolution parameter. The method was validated by determining its accuracy, precision, linearity and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise, linear and accurate, which is useful for the routine estimation of percentage drug release of Eletriptan Hydrobromide in oral film dosage form.
Keywords:
Eletriptan Hydrobromide, Oral Films, HPLC, DissolutionDOI
https://doi.org/10.25004/IJPSDR.2015.070608References
2. Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of fast dissolving buccal films: A Review. Der Pharm Lettre. 2011; 3(1): 152-165.
3. Bhyan B, Jangra S. Formulation and evaluation of fast dissolving sublingual films of Rizatriptan benzoate. Int J Drug Dev Res. 2012; 4:133-143.
4. Singh PK, Dinda SC. Development and validation of a stability indicating RP-HPLC method for determination of Eletriptan Hydrobromide orally disintegrating tablets. Int Res J Pharma. 2013; 4(6): 179-182.
5. Suneetha D, Laxmanarao A. RPHPLC method for the determination of Eletriptan Hydrobromide in pharmaceutical dosage form. Int J Chem Envl Pharm Res. 2010; 1(2): 95-99.
6. Cooper JDH, Muirhead DC, Taylor JE. Determination of eletriptan in plasma and saliva using automated sequential trace enrichment of dialysate and high-performance liquid chromatography. J Pharm Biomed Anal. 1999; 21(4): 787-796.
7. Balaji N, Sivaraman VR, Neeraja P. A validated UPLC method for the determination of process related impurities in Antimigraine bulk drug. IOSR-JAC. 2013; 3: 20-28.
8. Lakshamana Rao A, Suneetha D. RP-HPLC method for the estimation of Eletriptan in Pharmaceutical dosage forms. Int J Chem Env Pharma Res. 2010; 1(2):95-99.
9. Naik DS, Ramadevi K, Bhagawan D. Method Develop and Validation of Eletriptan Hydrobromide Pharmaceutical dosage form By RP HPLC. Int. Journal of Engineering Research and Applications 2013: 3(6): 1-5.
10. Sethi PD. High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations, 1st Edn. CBS Publishers and Distributors, New Delhi, 2001.
11. United States Pharmacopoeia, NF 21, Asian Edn., United States Pharmacopoeial Convention, Inc. Web com Ltd., 2003, pp. 22-78.
12. The Merck Index 13th Edition, Merck Research Laboratories Division of Merck Co. Ind., Whitehouse Station, NJ, 2001, pp. 1018-1025.
13. US Patent no. 5545644, E John Macor J Martin Wythes. Indole Derivatives, 1996.
14. US Patent no 6110940, Valerie Denise Harding et al. Salts of an anti-migraine indole derivative, 2000.
15. International Conference on Harmonization. ICH Harmonized Tripartite Guidelines (Nov 2005), Validation of Analytical Procedures, Text and Methodology Q2 (R1). ICH, Geneva, 2005.
16. ICH Q2B Validation of Analytical Procedures-Methodology. Consensus Guidelines, ICH Harmonized Tripartite Guidelines, 1996.
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