DEVELOPMENT AND VALIDATION OF ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF FAMOTIDINE IN BULK AND TABLET DOSAGE FORM
Â Objectives: The purpose of the study is to develop a simple, precise, economical, accurate, reproducible, and sensitive method for the estimation of famotidine (FAM) in bulk and its pharmaceutical dosage forms by ultraviolet (UV) absorption spectrophotometry.
Methods: The method uses 0.1 N HCl, pH 1.20 as a solvent for the quantitative estimation of FAM in bulk and its tablets dosage form by UV absorption spectrophotometry.
Results: FAM exhibited absorbance maxima at 266 nm in 0.1 N HCl, pH 1.20 solvent. The developed method was validated as per the ICH analytical method validation guidelines. Beer's law was obeyed in range of 0-30 Î¼g/ml with r2=0.9998. The limit of detection and limit of quantification values of FAM were found to be 0.152 and 0.461 Î¼g/ml, respectively. The mean percentage recovery for developed method was found to be in the range of 99.35-99.48%, respectively, for the marketed dosage forms. The developed method was also found to be robust and ensures bench-top stability.
Conclusion: The developed method was found to be suitable for the routine quantitative analysis of FAM in bulk and pharmaceutical dosage form. It was also concluded that developed UV spectrophotometry method was accurate, precise, linear, reproducible, robust, and sensitive.
2. United States Pharmacopoeial Convention. United States Pharmacopoeia 32, National Formulary 27. Vol. 2. Rockville MD: United States Pharmacopoeial Convention; 2009. p. 2342-5.
3. Connors KA. A Textbook of Pharmaceutical Analysis. 3rd ed. New York: Wiley Interscience Publication; 1999.
4. Mutaz A, Sheikh S, Hanan AN, Adnan BA. High pressure liquid chromatographic analysis and dissolution of famotidine in tablet formulation. Anal Lett 1989;22:2501-5.
5. Campbell AN, Sherma J. Determination of famotidine in acid reduction tablets by HPTLC and video densitometry of fluorescence quenched zones. J Liquid Chromatogr Relat Technol 2003;26:2719-22.
6. Kalsi PS. Spectroscopy of Organic Compounds. 6th ed. New Delhi: New Age International Publishers; 2012.
7. Walash MI, Sharaf-El-Din MK, El-Sayed MM, Shabana MR. Spectrofluorimetric determination of famotidine in pharmaceutical preparations and biological fluids. Application to stability studies. J Fluoresc 2009;19:333-44.
8. Tang YH, Wang NN, Xiong XY, Xiong FM, Sun SJ. A new sensitive flow-injection chemiluminescence method for the determination of H(2)-receptor antagonists. J Biolumin Chemilumin 2007;22:343-8.
9. Ayad MM, Shalaby A, Abdellatef HE, Elsaid HM. Potentiometric determination of famotidine in pharmaceutical formulations. J Pharm Biomed Anal 2002;29:247-54.
10. Ibrahim WM, Sharaf-El-Din MK, El-Sayed MM, Shabana MR. Polarographic determination of famotidine through complexation with Nickel(II) Chloride. J Chin Chem Soc 2005;52:927-35.
11. ICH, Q2A. Text on Validation of Analytical Procedures. International Conference on Harmonization. Geneva: October; 1994.
12. Skoog DA, Holler FJ, Crouch SR. Instrumental Analysis. 11th ed. Delhi:
Cengage Learning India Pvt. Ltd.; 2012.
13. Sharma YR. Introduction of Organic Spectroscopy. 4th ed. New Delhi: CBS Publishers and Distributors; 1991.
14. Huber L. Validation of analytical methods and processes. In: The Pharmaceutical Codex: Principles and Practice of Pharmaceutics. 12th ed. London: The Pharmaceutical Press; 1994. p. 507-24.
15. Miller JC, Miller JN. Statistics and Chemometrics for Analytical Chemistry. 5th ed. Harlow: Pearson Education Limited; 2005.
16. Manasa P, Jaffer SK, Ashwini M, Kumar AA. A simple and a cheap UV assay method development and validation for the estimation of eplerenone in tablet. Int J Pharm Pharm Sci 2015;7:348-51.
17. ICH, Q2 (R1). Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization. Geneva: November; 2005.
18. Davidson AG. Ultraviolet-visible absorption spectrophotometry. In: Beckett AH, Stenlake JB, editors. Practical Pharmaceutical Chemistry. Part 2. 4th ed. New Delhi: CBS Publishers and Distributors; 2002. p. 275-337.
19. Nash RA, Wachter AH, editors. Pharmaceutical Process Validation. New York: Markel Dekker, Inc.; 2008.
20. Singh S, Sharma N, Singla YP, Arora S. Development and validation of UV-spectrophotometric method for quantitative estimation of nefopam hydrochloride in polymethacrylate nanospheres. Int J Pharm Pharm Sci 2015;8(1):414-9.
21. Game MD, Sakarkar DM, Gabhane KB, Tapar KK. Validated spectrophotometric methods for the determination of cefuroxime axetil in bulk drug and tablets. Int J Chem Technol Res 2010;2(2):1259-62.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.