Abstract
The study of validation parameters of the quantitative determination method of riboflavin by specific absorbance and their assessment have been conducted in order to standardize procedures for analysis by the specific absorbance and the stage-by-stage control of correctness of the results obtained during the validation experiment. According to the requirements of the State Pharmacopoeia of Ukraine (SPhU) the qualification of the spectrophotometer has been performed. The control of the cells (δdif ≤ 0.002), absorbance accuracy, absorbance convergence with removing the cells (RSD0 0.0007% ≤ 0.25%), as well as the study of the limit of stray light (absorbance of the solution at the wavelength of 198 nm is 2.56 ≥ 2.0, which meets the requirements of SphU) have been carried out. Characteristics and acceptance criteria of the assay method for riboflavin such as the nominal concentration of the substance in solution by the method, the nominal absorbance and requirements for its minimum value, the maximum uncertainty of the analysis procedure have been theoretically calculated. The linearity parameter has been studied at 9 points. The linear dependence plot has been constructed in the normalized coordinates. The values of b, sb, a, sa, RSD0 and r calculated comply with the requirements to parameters of the linear dependence. When studying the parameter of accuracy the systematic error is δ = 0.72%, which meets δ ≤ 1.00%. According to the results of the convergence study the relative confidence interval ΔAs = 0.83% does not exceed the critical value for convergence of the results ΔAs = 0.96%. The validation parameters of the method meet the requirements of the SPhU and are characterized by qualitative analytical indicators.
Highlights
The literature review has revealed the fact that today new methods for quality control of riboflavin have been developed using HPLC [1, 9], electrophoretic extraction [5], voltammetry [6]
The aim of our work is to study the validation parameters of the quantitative determination method of riboflavin using the spectrophotometry method by specific absorbance in order to standardize procedures for analysis by the specific absorbance and the stage-bystage control of correctness of the results obtained during the validation experiment
Experimental Part When conducting the research the substance of riboflavin manufactured by Hebei Guangji Pharmaceutical Co., Ltd, No H201005030FM meeting the requirements of the State Pharmacopoeia of Ukraine (SPhU) was used
Summary
The compensation solution was prepared in the same way as the solution of the substance using all components except riboflavin. The measurements were performed with 1-cm cells at (20±1)°C. The statistical processing of the experimental data was carried out according to the Article of the SPhU “Statistical analysis of the chemical experiment” N [3]
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