STANDARDIZATION OF THE ACTIVE PHARMACEUTICAL SUBSTANCE α(1,2)-L-RAMNO- α(1,4)-D-GALACTOPYRANOSYLURONANE
Abstract
The aim of the research was the standardization of the pharmaceutical substance α(1,2)-L-rhamno-α(1,4)-D-galactopyranosyluronane and the development of a draft specification.
Material and methods. The object of the study is the pharmaceutical substance α(1,2)-L-rhamno-α(1,4)-D-galactopyranosyluronane Acorus calamus L. Authenticity was established by infrared spectroscopy. The quantitative content was determined by spectrophotometry. The validation of the methods was established in accordance with the Guidelines for the validation of analytical Methods for testing medicines and the State Pharmacopeia of the Russian Federation.
Results. The substance is an odorless white powder with a creamy tint, slowly soluble in water, the color of 5% aqueous solution is paler than the BY5 standard. The spectrum contains several characteristic absorption regions that differ from analogues of a hydrocarbon nature. The method of quantitative determination is linear in the concentration range of 0.01-0.50 mg/ml, the analytical range is 40-240%. When assessing the repeatability of the technique, the values of the relative standard deviation were in the range of 0.70-1.10%. When determining the correctness, the recovery percentage was 98.5-101.5%. The accuracy of the method for determining the molecular weight distribution was 4.09-4.84% (linear regression model). The protein content is less than 1.55%, heavy metals and arsenic are less than 0.0001%. The weight loss during drying is 2.11 for 011122 series and 1.68% for 031119 series, the pH of 1% solution is 3.05 and 3.08 respectively.
Conclusion. The substance α(1,2)-L-rhamno-α(1,4)-D-galactopyranosyluronane Acorus calamus L. has been standardized according to the declared indicators, a draft specification has been developed.
About the Authors
S. V. Krivoshchekov
ФГБОУ ВО «Сибирский государственный медицинский университет» Минздрава России
Russian Federation
Russian Federation
D. A. Isakov
ФГБОУ ВО «Сибирский государственный медицинский университет» Минздрава России
Russian Federation
Russian Federation
A. V. Zykova
ФГБОУ ВО «Сибирский государственный медицинский университет» Минздрава России
Russian Federation
Russian Federation
M. V. Belousov
ФГБОУ ВО «Сибирский государственный медицинский университет» Минздрава России
Russian Federation
Russian Federation
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Review
For citations:
Krivoshchekov S.V., Isakov D.A., Zykova A.V., Belousov M.V. STANDARDIZATION OF THE ACTIVE PHARMACEUTICAL SUBSTANCE α(1,2)-L-RAMNO- α(1,4)-D-GALACTOPYRANOSYLURONANE. Bashkortostan Medical Journal. 2024;19(1):36-41. (In Russ.)
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