DEVELOPMENT AND VALIDATION OF CYPHETRYLIN ASSAY IN TABLETS


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Abstract

Background. In N.N. Blokhin Russian Cancer Research Center have been synthesized a number of hypothalamic hormone somatostatin analogues, including pentapeptide cyphetrylin, and drug Cyphetrylin tablets 6 mg has been created. One of the drug standardization step is development of assay technique for acting substance in the final preparation. Objective. Development and validation of cyphetrylin assay in tablets. Materials and methods. The study used cyphetrylin, tablets 6 mg, сyphetrylin powder substance (FSBI “N.N. Blokhin Russian Cancer Research Center”, branch “Naukaprofi”), lactose monohydrate, cellulose microcrystalline, potato starch, povidone, talc, magnesium stearate (European Pharmacopoeia current edition), 95 % ethyl alcohol. Method of assay - spectrophotometry. Results. The technique for assay of сyphetrylin in drug “Cyphetrylin, tablets 6 mg” has been developed. Validation was performed to confirm test validity and accuracy. The technique was estimated by validation characteristics: specificity, linearity, accuracy, precision (repeatability and intermediate precision). Conclusion. The developed technique has the required characteristics: specificity, accuracy, repeatability, intermediate precision, linearity and can be used in the range of 70-130 % of nominal сyphetrylin content in preparation.

About the authors

Z. S. Shprakh

ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России

Author for correspondence.
Russian Federation

E. V. Ignatieva

ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России

Email: chem_analysis@ronc.ru
Russian Federation

I. V. Yartseva

ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России

Russian Federation

N. A. Dmitricheva

ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России

Russian Federation

L. I. Smirnova

ФГБУ «Российский онкологический научный центр им. Н.Н. Блохина» Минздрава России

Russian Federation

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