Abstract

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.

Highlights

  • Pharmaceutical dosage forms with diosmin are allowed for medical use in Russian Federation

  • 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 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%

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Summary

ФАРМАЦИЯ PHARMACY

ФАРМАЦЕВТИЧЕСКАЯ ХИМИЯ, ФАРМАКОГНОЗИЯ (14.04.02) PHARMACEUTICAL СHEMISTRY, PHARMACOGNOSY (14.04.02). Метрологические характеристики методики количественного определения диосмина в лекарственных препаратах // Аспирантский вестник Поволжья. Для контроля качества лекарственных препаратов необходимы простые и информативные методы анализа. Цель исследования — определение метрологических характеристик методики количественного определения диосмина методом спектрофотометрии в некоторых лекарственных препаратах. Значения удельных показателей поглощения диосмина при длинах волн 268 и 370 нм определяли по параметрам градуировочных зависимостей. Рабочий диапазон методики спектрофотометрического определения диосмина составил для аналитических длин волн: 268 нм — 0,0001–0,001 %, 370 нм — 0,0002–0,002 %. Значения удельных показателей поглощения диосмина при длинах волн 268 и 370 нм в растворе натрия гидроксида концентрации 0,02 моль/л составили 463,0 ± 24,6 и 259,0 ± 9,9 соответственно. Установлены величины вкладов в относительную ошибку методики количественного определения удельных показателей поглощения димосмина, а также степени извлечения диосмина из анализируемых лекарственных форм (на примере анализа таблеток «Детралекс»).

Aspirantskiy Vestnik Povolzhiya
Results
Материалы и методы
Результаты и обсуждение
Для всех анализируемых лекарственных препаратов наблюдали значимое отличие
Дисперсия выборки SSобщ эффекта MSэф межгрупповая SS ошибки MSошиб
Абсолютная ошибка σX
Full Text
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