Unification And Validation Of Hplc Method For The Quantitative Determination Of Fensulkal In A Substance And Combined Medicinal Mixtures
European Journal of Molecular & Clinical Medicine,
2020, Volume 7, Issue 8, Pages 1284-1295
Abstract
Research objective: to carry out studies on the optimization of the analysis conditions of HPLC and to create highly effective and theoretically substantiated methods for the qualitative and quantitative determination of dosage forms of complex compositions containing fensulkal.Material and methods. During the research,HPLC method was applied, with determination of the main chromatographic parameters of fensulkal: retention time, retention factor, spectral ratios, concentration of the organic component in the mobile phase. For the studies we used standard and test sample solutions of fensulkal and cetirizine (in combined model mixtures).
Findings.HPLC methods for the analysis of fensulkal in the substance and model mixturecombined with cetirizine were developed and unified as end-to-end methods.Besides,the optimal conditions for the analysis were selected.The methods were certified and validated according to the criteria: "Linearity", "Convergence", "Trueness" and can be included in the normative document for fensulkal and cetirizine substances,as well as other combined medicinal remedies for quality control according to indicators "Identification" and "Quantitative determination".
Conclusion.On the basis of the conducted studies, the unified HPLC method was developed as end-to-end method for the analysis and standardization of drugs containing fensulkal in the model mixtures and dosage forms. The developed unified method is validated according to the indicators "Linearity", "Trueness", and "Convergence", and can be included in the ND for standardization and quality control of drugs containing fensulkal according to the above indicators.
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