DOI: https://doi.org/10.15587/2519-4852.2018.122975

Verification of dissolution test for doxycycline hyclate in capsules to implement into the pharmacopoeial monograph

Anna Dobrova, Olga Golovchenko, Victoria Georgiyants

Abstract


The study of dissolution profiles is important as a cheap and easy supplement to bioequivalence research, and as a variation to such studies. This method is not outlined in the State Pharmacopoeia of Ukraine for the doxycycline capsules. Therefore, according to the current requirements, it was necessary to verify the procedure recommended by the US Pharmacopeia to confirm that this laboratory test will be reproduced correctly, and to use it in our further studies.

The aim of our research was to verify the "Dissolution" test analytical procedure for doxycycline hyclate capsules, recommended by the US Pharmacopoeia.

Methods. Capsules of doxycycline hyclate 100 mg and set of mineral waters were taken as study objects. A standard sample of doxycycline was used for preparation the comparison solutions. All reagents and test specimens meet the requirements of the SPhU. The experimental data were obtained at the same time in a standardized procedure. For this purpose, 9 points were studied within the range 55-135 % with a step of 10 %. The obtained results were processed statistically in accordance with the requirements of the SPhU.

Results. The conducted prediction showed that the total uncertainty of the results of the methodic is 1.04 %, which does not exceed the critical value (3.0 %). To determine the specificity, the effect of placebo was investigated. The calculation showed that the overall effect of placebo on the total absorption of the drug is non-significant (0.51 % ≤ 0.96 %). Also, the method is linear in the range of concentrations from 55 % to 135 %. The systematic error of the results meets the recommended criteria.

Conclusions. The analysis of model mixtures of doxycycline hyclate showed the correctness of the investigated method


Keywords


doxycycline hyclate capsules; verification; implementation; dissolution test; linearity; permissibility criteria; correctness of the procedure

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References


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GOST Style Citations


Kozlov R. S., Holub A. V. Mesto doksitsyklina v sovremennoi klinicheskoi praktike // Meditsinskii sovet. 2014. Vol. 9. P. 118–124.

Sexually Transmitted Diseases Treatment Guidelines, 2010. Vol. 59. Centers for Disease Control and Prevention. MMWR. 2010. 110 p.

Study of anti-inflammatory activity of compounds on the basis of doxycycline hydrochloride and glucosamine hydrochloride / Zupanets I. A., Tkachenko K. M., Otrishko I. A., Grintsov Ye. F. // Ukrayinskii zhurnal klinichnoy ta laboratornoy medycyny. 2014. Vol. 9, Issue 3. P. 37–40.

Sapadin A. N., Fleischmajer R. Tetracyclines: Nonantibiotic properties and their clinical implications // Journal of the American Academy of Dermatology. 2006. Vol. 54, Issue 2. P. 258–265. doi: 10.1016/j.jaad.2005.10.004

State Pharmacopoeia of Ukraine. Vol. 1. Kharkiv: Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines, 2014. 724 p.

United States Pharmacopeia 39. Vol. 1. Rockville: USP Convention Inc., 2016. URL: http://www.usp.org/sites/default/files/usp/document/our-work/biologics/USPNF810G-GC-1132-2017-01.pdf

Pharmaseutical analysis / Bezugly P. O., Georgiyants V. A., Grytsenko I. S. et. al.; Georgiyants V. A. ed. Kharkiv: Golden pages, 2013. 552 p.

Kumar A., Nanda S., Chomwal R. Spectrophotometric methods for determination of doxycycline in Tablet formulation // International Journal of ChemTech Research. 2010. Vol. 2, Issue 1. P. 599–602.

Test «Rastvorenie» і sovremennye podhody k ocenke ehkvivalentnosti lekarstvennyh preparatov (obzor) / Smekhova I. E., Perova Yu. M., Kondratyeva I. A., Rodygina A. N., Tureckova N. N. // Drug development and registration. 2013. Vol. 1, Issue 2. P. 50–61.

Grebenkin D. Yu., Stanishevskiy Ya. М., Shohin I. Е. Sovremennye podhody k provedeniyu sravnitelnogo testa kinetyki rastvorenia (obzor). Drug development and registration. 2016. Vol. 1, Issue 14. P. 166–171.

Gryzodub A. I. Standartnye procedury validacii metodik kontrolya kachestva lekarstvennyh sredstv. Farmakom. 2006. Vol. 1, Issue 2. P. 35–44.

Guidance on the validation of drug analysis procedures / Bagirova V. L., Gryzodub A. I., Chibilyaev T. H. et. al. Moscow: Farmatsevtycheskaia promishlennost. 2007. 58 p.

Analytical method validation and instrument performance verification / Chan C. C., Lam H., Lee Y. C., Zhang X.-M. Eds. Hoboken: JohnWiley&Sons, 2004. P. 11–51. doi: 10.1002/0471463728

Gryzodub A. I. Validaciya spektrofotometricheskih metodik kolichestvennogo analiza lekarstvennyh sredstv v sootvetstvii s trebovaniyami GFU. Farmakom. 2002. Vol. 3. P. 42–50. 







Copyright (c) 2018 Anna Dobrova, Olga Golovchenko, Victoria Georgiyants

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