THE DEVELOPMENT OF METHOD FOR THE SPECTROPHOTOMETRIC DETERMINATION OF A RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN A SEMI-FINISHED SOLUTION

Authors

DOI:

https://doi.org/10.11603/2312-0967.2019.4.10685

Keywords:

spectrophotometry, recombinant human interleukin-1 receptor antagonist, quantitative determination, semi-finished solution

Abstract

The aim of the work. The development and validation of the new spectrophotometric method for the quantitative determination of a recombinant human interleukin-1 receptor antagonist (IL-1RA) in a semi-finished solution.

Materials and Methods. Studying object – a semi-finished solution (IL-1RA 50 mg, disodium edetate – 0,12 mg, sodium dihydrophosphate dihydrate – 7,8 mg, polysorbate-20 – 0,10 mg, water for injection up to 1 ml). As a solvent, purified water was used. Analytical equipment: spectrophotometer Specord 200, electronic scales АВТ-120-5DM.

Results and Discussion. A new, simple method for the quantitative determination of a recombinant human IL-1RA in a semi-finished solution with the method of UV spectrophotometry has been developed, that is based on the measuring of the absorption of the aqueous solution at 280 nm. The method was validated for linearity, accuracy, precision, specificity, and robustness. The linear dependence of absorption on concentration was found in the range of 0,6 to 1,1 mg/ml. The analysis of the predicted total indeterminacy of the analysis indicates the possibility of its application in other laboratories.

Conclusion. The development and validation of the spectrophotometric method of quantitative determination of a recombinant human IL-1RA in a semi-finished solution according to the standardized validation procedure was carried out. It is proved that according to such validation characteristics as linearity, precision, correctness and robustness, the method is correct.

Author Biographies

K. P. Miedviedieva, Zaporizhzhia State Medical University

PhD (Pharmacy), Senior Lecturer of the Analytical Chemistry Department

B. S. Burlaka, Zaporizhzhia State Medical University

Associate Professor of the Drug Technology Department

V. V. Buhaiova, Zaporizhzhia State Medical University

Assistant Lecturer of the Analytical Chemistry Department

S. O. Vasyuk, Zaporizhzhia State Medical University

DS (Pharmacy), Professor, Chief of the Analytical Chemistry Department

I. F. Belenichev, Zaporizhzhia State Medical University

DS (Biology), Professor, Chief of the Pharmacology and Medical Prescription Department

E. V. Suprun, National University of Pharmacy

DS (Medicine), Professor of General Pharmacy and Safety of drugs IPHPQI

References

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Published

2019-12-13

How to Cite

Miedviedieva, K. P., Burlaka, B. S., Buhaiova, V. V., Vasyuk, S. O., Belenichev, I. F., & Suprun, E. V. . (2019). THE DEVELOPMENT OF METHOD FOR THE SPECTROPHOTOMETRIC DETERMINATION OF A RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN A SEMI-FINISHED SOLUTION. Pharmaceutical Review Farmacevtičnij časopis, (4), 29–36. https://doi.org/10.11603/2312-0967.2019.4.10685

Issue

No. 4 (2019)

Section

Analysis of drugs

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