The metrological parameters of diosmin quantitation in pharmaceutical dosage forms

Introduction. Pharmaceutical dosage forms with diosmin are allowed for medical use in Russian Federation. Simple and informative methods of diosmin quantitation for drug quality control are needed.

Aim: determination of metrological parameters of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry.

Matherials and methods. The study subjects Venarus®, Detralex® (tablets, suspension), Phlebopha®. Diosmin were quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 and 370 nm by the parameters of calibration were determined. Statistical data processing was carried out by the methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA).

Results. The range of diosmin quantitation by UV-spectrophotometry was revealed for the wavelength of 268 nm — 0,0001-0,001%, 370 nm — 0,0002-0,002%. The reference-specific absorbance values for diosmin at the wavelength of 268 and 370 nm in a sodium hydroxide solution 0,02M were 463,0 ± 24,6 and 259,0 ± 9,9 respectively. The mean errors of diosmin concentrations in pharmaceutical dosage forms were revealed for the wavelength of 268 nm — 8-12% and for 370 nm — 6-8%. Prognostic calculation of the sample preparation error (extraction) for diosmin was performed using the example of Detralex® tablets. The sample preparation error was 8%.

Conclusion. The values components of error for reference-specific absorbance value and sample preparation error for diosmin quantitation were determined (as exemplified by the study of Detralex® tablets). Calculation algorithms can be used for error estimation of sample preparation for other multicomponent samples in drug quality control.