An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker
Home >
2017,
Vol. 5 No. 2 > An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker
Published: November 2, 2017
Authors
- Ajinkya G. DhandarR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
- Suraj R. ChaudhariR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
- Saurabh B. GanorkarR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
- Amod S. PatilR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
- Sanjay J. SuranaR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
- Atul A. ShirkhedkarR.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, India
Keywords
BF, Bioanalytical, UPLC/LC-MS, capillary electrophoresis, impurity profile
Abstract
BF is Beta-adreno receptor antagonist and used as an AntiHypertensive Drug. BF gives the blocking action on β1-adrenergic receptors in the heart and vascular smooth muscle. The present review compiles the various approaches implemented for quantification of BF in bulk drug, pharmaceutical matrix and biological fluid. This review represents more than 50 analytical methods which include capillary electrophoresis, HPLC, HPTLC, UV-Spectroscopy, UPLC, impurity profiling and electrochemical methods implemented for estimation of BF as a single component as well as in multicomponent.
References
- Cheymol, G., Poirier, J.M., Carrupt, P.A., Testa, B., Weissenburger, J., Levron, J.C. and Snoeck, E.,et al. 1997. Pharmacokinetics of β-adrenoceptor blockers in obese and normal volunteers. British journal of clinical pharmacology, 43(6), 563–570. https://doi.org/10.1046/j.1365-2125.1997.00609.x
- Joshi, S.J., Karbhari, P.A., Bhoir, S.I., Bindu, K.S. and Das, C., 2010. RPHPLC method for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet formulation. Journal of pharmaceutical and biomedical analysis, 52(3), 362–371. https://doi.org/10.1016/j.jpba.2009.10.021
- Baokar, S.S., Erande, S.R. and Shaikh, G.S., 2011. Analytical method development and validation for simultaneous determination of bisoprolol fumarate and amlodipine besylate. Indo american j pharm res, 2(1), 100–110.
- Tjandrawinata, R.R., Setiawati, E., Yunaidi, D.A., Santoso, I.D., Setiawati, A. And Susanto, L.W., 2012. Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects. Drug design, development and therapy, 6, 311.
- Leopold, G., Pabst, J., Ungethüm, W. and Bühring, K.U., 1986. Basic Pharmacokinetics of Bisoprolol, a New Highly Beta1-selective Adrenoceptor Antagonist. The Journal of Clinical Pharmacology, 26(8), 616–621. https://doi.org/10.1002/j.1552-4604.1986.tb02959.x
- Neutel, J.M., Smith, D.H. and Weber, M.A., 2001. Low-dose combination therapy: an important first-line treatment in the management of hypertension. American journal of hypertension, 14(3), 286–292. https://doi.org/10.1016/S0895-7061(00)01310-8
- United state pharmacopeia (USP) by authority of the united state Pharmacopoeial convention Inc., meeting at Washington, DC, April 12–16, 2000.
- Panainte, A.D., Bibire, N., Tantaru, G., Apostu, M., Vieriu, M. and Dorneanu, V., 2014. A new method for the assay of bisoprolol using bromocresol green. REV CHIMBUCHAREST, 65(8), 916–920.
- Bobade, P.S. and Ganorkar, S.B., 2017. Establishing Pharmaceutical Brand Variability for Bisoprolol Fumarate and Hydrochlorothiazide Combinations: As an applied Q absorbance Spectrophotometry. Pharmaceutical Methods, 8(1).
- Gudruman, A.D., Murrasu, A. and Dorneanu, V., 2012. Spectrophotometric determination of bisoprolol using methyl orange as reagent. Farmacia, 60(5), 634.
- GawarkarPriyanka S., GavarkarPratibha S.V 2015 development and validation of uv spectrophotometric methods for simultaneous estimation of amlodipine besylate and bisoprolol fumarate in pure and tablet dosage form, International Journal of Universal Pharmacy and Bio Sciences 4(3): May-June 2015, 107–117.
- Gudruman, A.D.P., Bibire, N., Tantaru, G., Apostu, M., Vieriu, M. and Dorneanu, V., 2013. Validation of a New Spectrophotometric Method for the Assay of Bisoprolol Fumarateusing Tropaeolin 00. REV. CHIM. (BUCHAREST), 393–396.
- Tuljarani G., GowriSankar D. v 2010 quantitative determination of bisoprolol fumarate in bulk and pharmaceutical dosage forms by Spectrophotometry, Int. J. Chem. Sci.: 8(4), 2010, 2253–2258
- Abdelmonem, A.A., Ragab, G.H., Hashem, H.A. and Bahgat, E.A., 2016. Spectroflurometric and spectrophotometric determination of irbesartan and bisoprolol hemifumarate independently in their tablets. UK J Pharm Biosci, 4(2), 43–52. https://doi.org/10.20510/ukjpb/4/i2/97093
- Ashour, S., Al-Khalil, R. and Alfares, B., 2014. Hydrochlorothiazide Used as Diuretic with Antihypertensive Agents in Pharmaceutical Preparations. Estimation by First-Order Derivative and Extractive Spectrophotometry.
- Akram, M., Didamony, E.L., Hafeez, S. and Saad, A., 2015. Extraction spectrophotometric determination of some antihypertensive drugs in pharmaceuticals and biological fluids using two sulphonphthalein dyes. Int J Appl Pharm, 7, 10–7.
- EL-Didamony, A.M., Saad, M.Z. and Ramadan, G.M., 2012. Kinetic spectrophotometric determination of β-adrenergic antagonists using alkaline potassium permanganate. Main Group Chemistry, 11(4), 245–258.
- Atul, A.S., Rajesh, R.T. and Sanjay, J.S., 2008. Simultaneous spectrophotometric estimation of Bisoprolol fumarate and hydrochlorothiazide in tablet dosage form. Pakistan Journal of Pharmaceutical Sciences, 21(4).
- Joshi, S.J., Karbhari, P.A., Bhoir, S.I., Bindu, K.S. and Das, C., 2010. RPHPLC method for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in tablet formulation. Journal of pharmaceutical and biomedical analysis, 52(3), 362–371. https://doi.org/10.1016/j.jpba.2009.10.021
- Bozal, B., Gumustas, M., Topal, B.D., Uslu, B. and Ozkan, S.A., 2013. Fully validated simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in their dosage forms using different voltammetric, chromatographic, and spectrophotometric analytical methods. Journal of AOAC International, 96(1), 42–51. https://doi.org/10.5740/jaoacint.11-364
- Vora, D.N. and Kadav, A.A., 2008. Development and validation of a simultaneous HPLC method for estimation of bisoprolol fumarate and amlodipine besylate from tablets. Indian journal of pharmaceutical sciences, 70(4), 542. https://doi.org/10.4103/0250-474X.44616
- Siva Shankar Rao G., Parameswara Rao K. 2015. Development and Validation of RP-HPLC Method for the Assay of Bisoprolol in Pure and Formulations. Indian journal of pharmacy and pharmaceutical research 3 (1): 15–24.
- Rudwan, E.H., Mohammed, A.B. and Saeed, A.E., UV Derivative Spectrophotometric Method for Determination of Bisoprolol Fumarate in Bulk and Tablet Formulation.
- Baokar, S.S., Erande, S.R. and Shaikh, G.S., 2011. Analytical method development and validation for simultaneous determination of Bisoprolol fumarate and amlodipine besylate. Indo American J Pharm Res, 2(1), 100–110.
- Mostafa A, El-Gindy A, Emara S (2017) Simultaneous Spectrophotometric Estimation of Bisoprolol Fumarate and Hydrochlorothiazide in Tablet Formulation using Partial Least-Squares, Principal Component Regression Multivariate Calibrations and RP-HPLC Methods. J Anal Pharm Res 4(6):00124. https://doi.org/10.15406/japlr.2017.04.00124
- Hefnawy, M.M., Sultan, M.A. and Al-Shehri, M.M., 2006. Development of an HPLC method for the quantitation of bisoprolol enantiomer in pharmaceutical products using a teicoplanin chiral stationary phase and fluorescence detection. Journal of liquid chromatography & related technologies, 29(20), 2901-2914. https://doi.org/10.1080/10826070600978302
- Raju, D.S., Vidyadhara, S., Rao, B.V. and Madhavi, D., 2016. A modified liquid chromatographic method development and validation for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide in bulk and tablet dosage form. International Journal of Pharmaceutical Sciences and Research, 7(7), 2996.
- Panainte, A.D., Vieriu, M., Tântaru, G., Apostu, M. and Bibire, N., fast RP-HPLC method for the determination of bisoprolol.
- Mahu, S.C., Spac, A.F., Ciobanu, C., Hancianu, M., Agoroaei, L. and Butnaru, E., Quantitative determination of bisoprolol fumarate by HPLC.
- Dobricic, V., Vulovic-Tadic, M., Jancic-Stojanovic, B., Vladimirov, S. and Cudina, O., 2016. Desirability based optimization and validation of new RP-HPLC method for simultaneous determination of bisoprolol fumarate, hydrochlorothiazide and their impurities. chromatographia, 79(9-10), 571–579.
- Agapova, N.N. and Vasileva, E., 1993. High-performance liquid chromatographic method for the determination of bisoprolol and potential impurities. Journal of Chromatography A, 654(2), 299–302. https://doi.org/10.1016/0021-9673(93)83373-Z
- Ganipisetty, V.N.R., Jalandhar, D., Gnanadev, G., Manoj, P. and Venkata Nadh, R., 2016. A novel reversed-phase liquid chromatographic method for the simultaneous determination of potential impurities of bisoprolol fumarate and hydrochlorothiazide in a fixed dosage form. Separation Science and Technology, 51(8), 1362–1369. https://doi.org/10.1080/01496395.2016.1154873
- Zhou, J., Pei, W., Su, N., Liu, Q., Fu, G. and Zhang, Z., 2013. Separation of fourlol drugs by HPLC with new bonded chiral stationary column. Chinese Science Bulletin, 58(11), 1267–1273. https://doi.org/10.1007/s11434-012-5636-7
- Marothu, V.K., Yerramothu, P., Gorrepati, M., Majeti, S., Mamidala, S.K. and Nellutla, A., 2015, November. Application of HPLC to assess the compatibility of bisoprolol fumarate with selected excipients in mixtures by isothermal stress testing. In Annalespharmaceutiquesfrancaises 73(6): 442–451). Elsevier Masson. https://doi.org/10.1016/j.pharma.2015.05.001
- Oniscu, C., Vlase, C.V. and Peste, G.G., 2007. A new high performance liquid chromatographic method for determination of bisoprolol in plasma samples. Romanian Biotechnological Letters, 12(1), 3079.
- Peste, G., Oniscu, C. and Vlase, A., 2010. Experimental research for determination of bisoprolol fumarate in human plasma samples using liquid chromatographytandem mass spectrometry (LC-MS/MS) technique. Romanian Biotechnological Letters, 15(2), 5141.
- Zhang, M., Li, Q., Ji, W., Jiang, S., Ma, C., Wang, C., Ye, J., Cui, Y., Liu, W., Bi, K. and Chen, X., 2011. Three-phase solvent bar microextraction combined with HPLC for extraction and determination of plasma protein binding of bisoprolol. Chromatographia, 73(9-10), 897–903. https://doi.org/10.1007/s10337-011-1982-x
- Mitrevska, I., Kikovska-Stojanovska, E., Petrusevski, G., Chachorovska, M., Memed-Sejfulah, S. and Ugarkovic, S., 2017. Identification and Structural Characterization of Unidentified Impurity in Bisoprolol Film-Coated Tablets. Advances in Chemistry, 2017.
- Athota, R.V., Jagarlapudi, S.K. and Singampalli, M.R., 2016. Stability Indicating RP-HPLC Method for Simultaneous Assay of Bisoprolol and hydrochlorothiazide in combined tablet dosage form. International journal of pharmtech research, 9(7), 329–339.
- Renuka, P., Ramakrishna, M. and Babu, DM. 2016. A new chromatographic method developed stability indicating for the simultaneous estimation of bisoprolol and hydrochlorthiazide in pharmaceutical dosage forms.
- Bhoya, P.N. and Patelia, E.M., 2013. Chromatography development and validation of TLC-densitometry method for simultaneous estimation of Bisoprolol fumarate and Hydrochlorothiazide in bulk and tablets. Journal of Chromatography and Separation Techniques, 4(1), 1–4.
- Patel, D.R., Mashru, R.C. and Patel, M.M., 2011. Enantioseparation of bisoprololfumarate by TLC and HPTLC using (+)-10-camphorsulphonic acid as a chiral selector. IJPT, 3(1), 1593–1602.
- Yadav, S.S. and Rao, J.R., 2013. Simultaneous HPTLC analysis of bisoprololfumarate and hydrochlorthiazide in pharmaceutical dosage form. Int J Pharm PharmSci, (52), 286–90.
- Madhusudhanareddy, I., Bhagavan, R.M. and Rajendra, P.Y., 2012. Validated and stability indicating liquid chromatography method for quantification of bisoprolol fumarate tablet dosage form. International Journal of Pharmacy, 2(1), 64–70.
- Vujanović, I.K., Jelić, D., Antunović, V., Stojanović, B.J. and Ivanović, D., 2014. Stability study of amlodipine besylate and bisoprolol Fumarate in aqueous solutions. Contemporary Materials, 2(5), 212–221.
- Athota, R.V., Jagarlapudi, S.K. and Singampalli, M.R., 2016. Stability Indicating RP-HPLC Method for Simultaneous Assay of Bisoprolol and Hydrochlorothiazide in Combined Tablet Dosage Form. International Journal of PharmTech Research, 9(7), 329–339.
- Kasagic-Vujanovic, I., Stojanovic, B.J. and Ivanovic, D., 2017. Monitoring of bisoprolol fumarate stability under different stress conditions. In CMBEBIH 2017 (415–424). Springer, Singapore. https://doi.org/10.1007/978-981-10-4166-2_64
- Kurbanoglu, S., San Miguel, P.R., Uslu, B. and Ozkan, S.A., 2014. Stabilityindicating UPLC method for the determination of bisoprolol fumarate and hydrochlorothiazide: application to dosage forms and biological sample. Chromatographia, 77(3-4), 365–371. https://doi.org/10.1007/s10337-013-2606-4
- Kurbanoglu, S., San Miguel, P.R., Uslu, B. and Ozkan, S.A., 2014. Stabilityindicating UPLC method for the determination of bisoprolol fumarate and hydrochlorothiazide: application to dosage forms and biological sample. Chromatographia, 77(3-4), 365–371. https://doi.org/10.1007/s10337-013-2606-4
- Gagyi, L., Gyeresi, A. and Kilar, F., 2006. Role of chemical structure in stereoselective recognition of beta-blockers and H1-antihistamines by human serum transferrin in capillary zone electrophoresis. Electrophoresis, 27(8), 1510–1516. https://doi.org/10.1002/elps.200500787
- Duan, H.B., Cao, J.T., Wang, H. and Liu, Y.M., 2015. Determination of metoprolol tartrate and bisoprololfumarate by capillary electrophoresis coupled with tris (2, 2′ bipyridyl)-ruthenium (ii) electrochemiluminescence detection and study on the interaction between the drugs and human serum albumin. Analytical Methods, 7(9), 3946–3951. https://doi.org/10.1039/C5AY00336A
- Wang, J., Zhang, X., Pi, F., Wang, X. and Yang, N., 2009. Tris (2, 2′-bipyridyl) ruthenium (II)–bisoprolol-based electrochemiluminescence coupled with capillary zone electrophoresis. ElectrochimicaActa, 54(8), 2379–2384. https://doi.org/10.1016/j.electacta.2008.10.066
- Gagyi, L., Gyeresi, Á. and Kilar, F., 2008. Role of chemical structure in stereoselective recognition of β-blockers by cyclodextrins in capillary zone electrophoresis. Journal of biochemical and biophysical methods, 70(6), 1268–1275. https://doi.org/10.1016/j.jbbm.2007.10.004
- Bansal, S. and DeStefano, A., 2007. Key elements of Bioanalytical method validation for small molecules. The AAPS journal, 9(1), E109–E114. https://doi.org/10.1208/aapsj0901011
- Tatar Ulu, S. and Aydogmuş, Z., 2012. An HPLC method for the determination of bisoprolol in human plasma and its application to a pharmacokinetic study. Journal of chromatographic science, 50(7), 615–619. https://doi.org/10.1093/chromsci/bms056
- Chang, H., Li, J., Li, J., Guan, X., Sun, F., Qian, Z., Bi, K. and Fan, G., 2012. Simultaneous determination of amlodipine and bisoprolol in rat plasma by a liquid chromatography/tandem mass spectrometry method and its application in pharmacokinetic study. Journal of pharmaceutical and biomedical analysis, 71, 110. https://doi.org/10.1016/j.jpba.2012.08.012
- Peste, G., Bibire, N., Apostu, M., Vlase, A. and Oniscu, C., 2009. A new liquid chromatography-tandem mass spectrometry method for determination of bisoprolol in human plasma samples. BioMed Research International, 2009. https://doi.org/10.1155/2009/736327
- Zhang, M., Li, Q., Ji, W., Jiang, S., Ma, C., Wang, C., Ye, J., Cui, Y., Liu, W., Bi, K. and Chen, X., 2011. Three-phase solvent bar microextraction combined with HPLC for extraction and determination of plasma protein binding of bisoprolol. Chromatographia, 73(9-10), 897–903. https://doi.org/10.1007/s10337-011-1982-x
- Caudron, E., Laurent, S., Billaud, E.M. and Prognon, P., 2004. Simultaneous determination of the acid/base antihypertensive drugs celiprolol, bisoprolol and irbesartan in human plasma by liquid chromatography. Journal of Chromatography B, 801(2), 339–345. https://doi.org/10.1016/j.jchromb.2003.11.009
- Oniscu, C., Vlase, C.V. and Peste, G.G., 2007. A new high performance liquid chromatographic method for determination of bisoprolol in plasma samples. Romanian Biotechnological Letters, 12(1), 3079.
- Braza, A.J., Modamio, P., Lastra, C.F. and Mario, E.L., 2002. Development, validation and analytical error function of two chromatographic methods with fluorimetric detection for the determination of bisoprolol and metoprolol in human plasma. Biomedical Chromatography, 16(8), 517–522. https://doi.org/10.1002/bmc.195
- Modamio, P., Lastra, C.F. and Marino, E.L., 1998. Transdermal absorption of celiprolol and bisoprolol in human skin in vitro. International journal of pharmaceutics, 173(1), 141–148. https://doi.org/10.1016/S0378-5173(98)00214-2
- Tilea, I., Muntean, D. and Tilea, B., experimental & clinical cardiology How to reference: Determination of Bisoprolol in Human Plasma by LC-MS/MS for Therapeutic Drug Monitoring.
- Saleem, K., Ali, I., Kulsum, U. and Aboul-Enein, H.Y., 2013. Recent developments in HPLC analysis of β-blockers in biological samples. Journal of chromatographic science, 51(8), 807–818. https://doi.org/10.1093/chromsci/bmt030
- Eastwood, R.J., Jerman, J.C., Bhamra, R.K. and Holt, D.W., 1990. High performance liquid chromatographic measurement of bisoprolol in plasma. Biomedical Chromatography, 4(4), 178–18. https://doi.org/10.1002/bmc.1130040415
- Dhangar, K.R., Jagtap, R.B., Surana, S.J. and Shirkhedkar, A.A., 2017. Review article impurity profiling of drugs towards safety and efficacy: Theory and Practice. Journal of the Chilean Chemical Society, 62(2). https://doi.org/10.4067/S0717-97072017000200024
- Guideline, I.H.T., 2005. Validation of analytical procedures: text and methodology. Q2 (R1), 1.
- Rakić, T., Jovanović, M., Tumpa, A., Jančić-Stojanović, B. and Medenica, M., Optimization of HILIC method for the analysis of bisoprolol and its impurities considering uncertainties in peak position.
- Mitrevska, I., Kikovska-Stojanovska, E., Petrusevski, G., Chachorovska, M., Memed-Sejfulah, S. and Ugarkovic, S., 2017. Identification and Structural Characterization of Unidentified Impurity in Bisoprolol Film-Coated Tablets. Advances in Chemistry, 2017.
- Ganipisetty, V.N.R., Jalandhar, D., Gnanadev, G., Manoj, P. and Venkata Nadh, R., 2016. A novel reversed-phase liquid chromatographic method for the simultaneous determination of potential impurities of bisoprolol fumarate and hydrochlorothiazide in a fixed dosage form. Separation Science and Technology, 51(8), 1362–1369. https://doi.org/10.1080/01496395.2016.1154873
- Goyal, R.N., Chatterjee, S., Singh, S.P., Rana, A.R.S. and Chasta, H., 2012. The Electrocatalytic Activity of Bare Pyrolytic Graphite and Single Wall Carbon Nanotube Modified Glassy Carbon Sensors Is Same for the Quantification of Bisoprolol Fumarate. American Journal of Analytical Chemistry, 3(02), 106. https://doi.org/10.4236/ajac.2012.32015
- Bozal, B., Gumustas, M., Topal, B.D., Uslu, B. and Ozkan, S.A., 2013. Fully validated simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in their dosage forms using different voltammetric, chromatographic, and spectrophotometric analytical methods. Journal of AOAC International, 96(1), 42–51. https://doi.org/10.5740/jaoacint.11-364
- Goyal, R.N., Tyagi, A., Bachheti, N. and Bishnoi, S., 2008. Voltammetric determination of bisoprolol fumarate in pharmaceutical formulations and urine using single-wall carbon nanotubes modified glassy carbon electrode. ElectrochimicaActa, 53(6), 2802–2808. https://doi.org/10.1016/j.electacta.2007.10.057
- Bazylak, G. and Nagels, L.J., 2002. Integrated acquisition of analytical and biopharmaceutical screening data for beta-adrenergic-drugs employing diversified macrocycle supported potentiometric detection in HPLC systems. Current medicinal chemistry, 9(16), 1547–1566. https://doi.org/10.2174/0929867023369475
- Hassan, S.S., Abou-Sekkina, M.M., El-Ries, M.A. and Wassel, A.A., 2003. Polymeric matrix membrane sensors for sensitive potentiometric determination of some β blockers in pharmaceutical preparations. Journal of pharmaceutical and biomedical analysis, 32(1), 175–180. https://doi.org/10.1016/S0731-7085(03)00015-3
How to Cite
Ajinkya G. Dhandar, Suraj R. Chaudhari, Saurabh B. Ganorkar, Amod S. Patil, Sanjay J. Surana , Atul A. Shirkhedkar. An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker.
J. Pharm. Technol. Res. Manag.. 2017, 05, 185-216
