Medicines with active pharmaceutical ingredient diosmin: plaining of sample preparation

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Abstract

BACKGROUND: Most drugs in the form of tablets contain diosmin in the micronized flavonoid fraction. This is the reason for the low level recovery by means of solid-liquid extraction.

AIM: to determine optimal conditions for sample preparation of some drugs with active pharmaceutical ingredient diosmin with the use of mathematical experiment planning (Box-Behnken design).

MATERIALS AND METHODS: The study subjects were tablets Detralex® 1000 mg, Venarus® 900 mg, Detravenol® 1000 mg, Flebaven® 1000 mg, Phlebopha® 600 mg, Phlebodia 600 mg. Estimation of diosmin recovery by the method of solid-liquid extraction was made according to the algorithm of full factorial design with three level factors (Box-Behnken design).

RESULTS: The effect of some factors determining the extraction of diosmin from tablets Detralex® 1000 mg, Venarus® 900 mg, Detravenol® 1000 mg, Flebaven® 1000 mg, Phlebopha® 600 mg, Phlebodia 600 mg was estimated. Mathematical (regression) models of solid-liquid extraction of diosmin for each drug were developed. The most significant factor determining the diosmin recovery from drugs (tablet formulation) is the sodium hydroxide concentration. Other factors (acetonitrile concentration, extraction time, centrifugation time, addition of ammonium sulfate) fail to exert significant effect. The optimal value of sodium hydroxide concentration is 0.02 mol/l. Diosmin recovery doesn’t increase after the increase of the sodium hydroxide concentration above 0.02 mol/l.

About the authors

Alexander V. Voronin

Samara State Medical University

Author for correspondence.
Email: a.v.voronin@samsmu.ru

Doctor of Pharmaceuticals Sciences, Associate Professor, Head of the Department of Chemistry, Institute of Pharmacy

Russian Federation, Samara

Alexander V. Karpov

Samara State Medical University

Email: karpov.sasha111@gmail.com

Postgraduate student, Department of Chemistry, Institute of Pharmacy

Russian Federation, Samara

References

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Categorized histogram (а), histogram of vairiability of the efficiency of diosmin extraction (b) from drugs through the example of tablets Detralex®, 1000 mg

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3. Fig. 2. Pareto charts of the standardized effects of diosmin extraction through the example of Venarus®, 900 mg (L — linear effects, Q — quadratic effects)

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4. Fig. 3. Response surface (a) and contour diagram (b) of the dependence of diosmin extraction recovery on factors X1 and X5 (through the example of Phlebopha®, 600 mg)

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Copyright (c) 2021 Voronin A.V., Karpov A.V.

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