Open AccessDEVELOPMENT AND VALIDATION OF CYPHETRYLIN ASSAY IN TABLETS
Author(s) -
З. С. Шпрах,
E. V. Ignatieva,
I. V. Yartseva,
Н. А. Дмитричева,
Л. И. Смирнова
Publication year - 2016
Publication title -
rossijskij bioterapevtičeskij žurnal
Language(s) - English
Resource type - Journals
eISSN - 1726-9792
pISSN - 1726-9784
DOI - 10.17650/1726-9784-2016-15-3-55-61
Subject(s) - magnesium stearate , repeatability , microcrystalline cellulose , chromatography , chemistry , dosage form , cellulose , biochemistry
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.