DOI: https://doi.org/10.22263/2312-4156.2023.4.88
O.A. Sushinskaya, N.S. Golyak
Validation of the method for the quantitative determination of ibuprofen in the spray for external use
Belarusian State Medical University, Minsk, Republic of Belarus
Vestnik VGMU. 2023;22(4):88-96.
Abstract.
The aim of the study was the development and validation of the method for quantitative determination of ibuprofen in a combined spray by high–performance liquid chromatography.
Material and methods. The object of the study was 3 pilot-industrial series of the spray containing ibuprofen 5%(m/m) and wormwood bitter herb liquid extract as active ingredients. The tests were carried out on a Zorbax Eclipse XBD C18 chromatographic column (size 250×4.6 mm, particle size 5 microns, Agilent), with a mobile phase consisting of phosphoric acid, water and acetonitrile for chromatography in a ratio of 0.5:660:340. Accuracy indicators, such as correctness, reproducibility and repeatability, and validation characteristics – specificity, linearity and robustness were the validation parameters of the quantitative determination of ibuprofen in the spray.
Results. As a result of validation of the analytical method, its specificity was proved, linearity was confirmed, the square of the correlation coefficient of the linear dependence is 0.9985. It has been shown that the method is applicable for the identification and quantitative determination of ibuprofen in a combined spray, the correctness of the method has been determined, the openability of which is from 99.44 to 103.04%. It has been shown that the analytical method has the necessary precision, the relative standard deviation in determining intra-laboratory reproducibility made up 1.54 and 0.98%, in assessing convergence it was 1.31%, which meets the necessary requirements. The ibuprofen content in the combined spray was 51.8±0.68 mg/g.
Conclusions. Validation tests have confirmed that the analytical technique is reliable, accurate and precise and can be used to identify and quantify ibuprofen in a spray, which makes it possible to recommend it both for routine quality control of the developed drug and for studying its stability.
Keywords: quantitative determination, ibuprofen, validation, high-performance liquid chromatography, spray, external use.
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Information about authors:
O.A. Sushinskaya – Master of Pharmaceutical Sciences, postgraduate of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-6801-7285
e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Olga A. Sushinskaya;
N.S. Golyak – Candidate of Pharmaceutical Sciences, associate professor, head of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-4904-6523
