Development of the “Dissolution” test for bisoprolol tablets
DOI:
https://doi.org/10.24959/nphj.14.1941Keywords:
bisoprolol, tablets, “Dissolution” test, spectrophotometry, validationAbstract
Bisoprolol is a lipophilic cardioselective β-blocker, which leads to its rapid and almost complete (90%) absorption out of the gastrointestinal tract and high bioavailability. For determination bioavailability of solid dosage forms for oral administration in the conditions of pharmaceutical companies and laboratories the “dissolution” test is performed; its results allow to judge about the technology of manufacturing the drug and its bioavailability. The test on dissolution of solid dosage forms is an integral part of measures ensuring the quality of medicines. The aim of the analysis is to develop the “dissolution” test for bisoprolol tablets by absorption spectrophotometry in the ultraviolet and visible spectra. As a result of the research, the conditions for conducting the “dissolution” test for bisoprolol fumarate tablets have been grounded: the device with the blade is used, the volume of the medium is 500 ml, the temperature of the solvent medium is 37°C, the solvent is 0.1 M hydrochloric acid, the rotation rate is 75 rpm/min, the dissolution time is 20 min. The spectrophotometric method of determination of bisoprolol fumarate in 0.1 M solution of hydrochloric acid at the wavelength of 272 nm has been developed. It has been determined that the tablet excipients do not prevent spectrophotometric determination. The results obtained have shown that for 20 minutes of dissolution more than 90% of the active substance of its label claim turns into the solution. The following validation properties do not exceed the eligibility criteria: robustness (the analytical solution is stable for an hour), linearity (a=0.97% ≤ max a, 1.92%; b=0.9931), the correlation coefficient (0.9999), accuracy (0.52% ≤ max δ, 0.96%) and repeatability (2.24% ≤ max Δas, 3.0%), precision (1.42% ≤ max Δas 3.0%), which allows us to recommend the procedure for use in pharmaceutical analysis.
References
Багирова В.Л., Гризодуб А.И., Чибиляев Т.Х. и др. Руководство по валидации методик анализа лекарственных средств. – М.: Фарм. пром., 2007. – 58 с.
Гризодуб А.И. Стандартизованные процедуры валидации методик контроля качества лекарственных средств // В кн.: «Аналитическое обеспечение создания, стандартизации и контроля качества лекарственных средств». – Х.: «НТМТ», 2011. – Т. 1. – С. 934-1063.
Гризодуб А.И., Леонтьев Д.А., Дмитриева М.В. // Фармаком. – 2006. – №4. – С. 39-50.
Державна фармакопея України / Державне підприємство «Науково-експертний фармакопейний центр». – 1-е вид. – Доп. 1. – Х.: Державне підприємство «Науково-експертний фармакопейний центр», 2004. – 520 с.
Державна фармакопея України / Державне підприємство «Науково-експертний фармакопейний центр». – 1-е вид. – Доп. 2. – Х.: Державне підприємство «Науково-експертний фармакопейний центр», 2008. – 620 с.
Лукина Ю.И., Марцевич С.Ю. // Рациональная фармакотерапия в кардиол. – 2010. – №6. – С. 103-107.
Deshmukh N.D., Thenge R.R., Mahajan N.M. // Intern. J. of Pharmac. Res. and Bio-Sci. – 2012. – Vol. 1, №5. – P. 364-378.
Public Assessment Report Decentralised Procedure Bisoprolol Fumarate 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg Film-Coated Tablets UK/H/1683/001-6/DC UK licence no: PL 32256/0083-88 Applicant: Aurobindo Pharma (Malta) Limited.
Тhe Japanese Pharmacopoeia. – 16th ed. – 2011. – Р. 463-464.
The United States Pharmacopeia. – 30th ed. (NF 25). – Rockville: United States Pharmacopeial Convention Inc., 2007. – 1070 p.
Downloads
Published
Issue
Section
License
Copyright (c) 2014 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
