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Analytical Method Development and Validation for Estimation of Brisoprolol Fumerate in Bulk and Pharmaceutical Dosage Form by UV Spectrometric Method

Swati S Rawat, Ganesh Dewan


The objective of the present work is to develop a new, rapid, simple, economical, precise, sensitive, linear and accurate, UV Spectrophotometric method has been developed. Phosphate buffer of pH 6.8 is used as solvent for the estimation of Brisoprolol Fumerate bulk and pharmaceutical formulation as per ICH guidelines. Spiked Brisoprolol Fumerate was checked over UV-visible extend for its wavelength of greatest absorbance. The wavelength of most extreme absorbance for Brisoprolol Fumerate was found to be 223nm. The relationship coefficient over the concentration extends of 10–50 µg/ml was found to be 0.997. The accuracy was carried out as per recovery study and found between 99.65%% to 100.45%The LOD and LOQ of Brisoprolol Fumerate was found to be 0.283 and 0.858 respectively. The method was successfully applied to estimate Brisoprolol Fumerate in prepared formulation and result were in good agreement with claims. Depending on the results, the given method can be successfully applied in estimation of Brisoprolol Fumerate.


UV Spectroscopy, Method Development, Validation, Brisoprolol Fumerate and ICH Guideline.

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Harvey, D. (2000) Modern Analytical Chemistry, 1st edition, McGraw-Hill Publication, Kingsport-USA, pg 1–2.

Skoog, D. A. et al. (2001) Principles of Instrumental Analysis, 5th edition, Thomson Books, Delhi, 11–16.

Pratik, P. et al. (2012) Spectrophotometric method Development and Validation for estimation of alpha lipoic acid in tablet dosage form, Intl J of Pharmaand Pharm sci., 5, 519–522.

Rawat, S. & Gupta, A. (2011) Regulatory Requirements for Drug Development and Approval in United States: A Review, Asian J. Pharm. Res, 1 (1), 01–06.

Rawat, S. & Gupta, A. (2011) Development of Novel HPTLC Method for Estimation of Qurcetine in Ocimum sanctum, Asian J. Pharm. Tech, 1 (4), 149–151.

Saengsirisuwan, V., Perez F.R., Sloniger, J. A., Maier, T., Henriksen, E.J. (2004) Interaction of exercise training and α-lipoic acid on insulin signaling in skeletal muscle of obese Zucker rats, Am. J. Physiol. Endocrinol. Metab., 287 (3): 529–536.

Burke, D.G., Chilibeck, P.D., Parise, G., Tarnopolsky, M.A., Candow, D.G. (2003) Effect of α-lipoic acid combined with creatine monohydrate on human skeletal muscle creatine and phosphagen concentration, Int. J. Spot. Nutr. Exerc. Metab., 13 (3): 294–302.

Evans, J.L., Heymann, C.J., Goldfine, I.D., Gravin, L.A. (2007) Antioxicants: Do they have a role in the treatment of insulin resistance? Antioxidants and Insulin resistance: Clinical studies, The Ind J Med Res., 125 (3): 360–61.

Suvarna, G. Bhokare, and Marathe, R.P. (2018) Novel Analytical Method Development and Validation for Estimation of Clinical Important Simvastatin in Bulk and Pharmaceutical Dosage Form by UV Spectrometric Method Using Phosphate Buffer Solubility, J. Biol. Chem. Chron., 4 (3), 17–23.

Thorat, S.S. and Gupta, A. (2018) Basic Concept of Stability Profile and Stress Degradation Pathway of Pharmaceutical Formulations: A Review, J. Biol. Chem. Chron., 4 (3), 34–42

British Pharmacopoeia (2009) The Department of Health, British Pharmacopoeia Commission, London, Vol. 2, pg 1410–1412.

Manohar. A. Potdar. Pharmaceutical quality assurance. Nirali prakashan,2nd edition 2010. page no: 8.1–8. 108.



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