Development and Validation of UV Spectrophotometric Method For Determination of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Forms


  • Shahinaz Mohammed
  • Mohammed Adam
  • Shaza Shantier University of Khartoum



In this study a simple, accurate and precise UV- spectrophotometric method was developed for the estimation of bisoprolol fumarate (BF) in bulk and tablet dosage form. The method was based on measurement of absorbance of BF aqueous solution at 271nm. Validation was conducted in accordance to ICH guidelines. The calibration curve was linear in the concentration range 5-25 µg/mL with correlation coefficient not less than 0.9986. The limit of detection and limit of quantification were 0.22 μg/ml and 0.66 μg/ml, respectively. Intraday and intermediate precision of the developed method were reflected by the low RSD% values (1.19 and 0.854, respectively). The recovery percentage was 105.0 ± 1.3%, n=3. The proposed method was applied for the assay of BF in three different brands


T.F. Ligenli, F. Kilicaslan, A. Kirilmaz, M. Uzun, Bisoprolol improves echocardiographic parameters of left ventricular diastolic function in patients with systemic hypertension, Cardiology, 2006, 106, 127-131.

J.K. Mc Gavin, G.M. Keating, Bisoprolol: A review of its use in chronic heart failure, Drugs, 2002, 62, 267-269.

R.N. Goyal, A. Tyagi, N. Bachheti, S. Bishnoi, Voltammetric determination of bisoprolol fumarate in pharmaceutical formulations and urine using single-wall carbon nanotubes modified glassy carbon electrode, Electrochimica Acta, 2008, 53, 2802-2808

R. Sahu, V.B. Patel, Simultaneous spectrophotometric estimation of hydrochlorothiazide and bisoprolol fumarate in combined dosage forms, Indian Journal of Pharmaceutical Sciences, 2006, 68, 764 - 767

A.D. Panainte, N. Bibire, G. Tantaru, M. Apostu, M. Vieriu, and V. Dorneanu, A new method for the assay of bisoprolol using bromocresol green. Rev. Chim. (Bucharest), 2014, 65(8), 916-920.

A.D. Panainte, N. Bibire, G. Tantaru, M. Apostu, M. Vieriu, and V. Dorneanu, Spectrophotometric method for the estimation of bisprolol fumarate in tablets, Rev. Med. Chir. Soc. Med. Nat lasi., 2014, 118 (2), 558-563.

A.D. Gudruman, A. Murarasu, and V. Dorneanu, Spectrophotometric determination of bisoprolol using methyl orange as reagent. Farmacia, 2012, 60(5), 634-640

D.N. Vora, A.A. Kadav, Development and validation of a simultaneous HPLC method for estimation of bisoprolol fumarate and amlodipine besylate from tablets, Indian Journal of Pharmaceutical Sciences, 2008, 70, 542-546

S. Shaikh, O.A. Thusleem, M.S. Muneera, J. Akmal, A.V. Kondaguli, K. Ruckmani, A simple and rapid high-performance liquid chromatographic method for the determination of bisoprolol fumarate and hydrochlorothiazide in a tablet dosage form, Journal of Pharmaceutical and Biomedical Analysis, 2008, 48, 1055-1057.

E. Caudron, S. Laurent, E.M. Billaud, P. Prognon, Simultaneous determination of the acid/base antihypertensive drugs celiprolol, bisoprolol and irbesartan in human plasma by liquid chromatography, Journal of Chromatography B, 2004, 801, 339-345.

C. Oniscu, C.V. Vlase, G. Peste, A new high-performance liquid chromatographic method for determination of bisoprolol in plasma samples, Romanian Biotechnological Letters, 2007, 12, 3079-3084.

K. Konam, J. Soujanya, M. Sasikala, and A.K. Kumar, Development and validation of RP-HPLC method for the determination of bisoprolol fumarate tablets. International Journal of Research in Pharmaceutical and Nano Sciences, 2013, 2(1), 57-58.

ICH G. Validation of analytical procedures: text and methodology. Q2 (R1). 2005;1.






Analytical Chemistry