VALIDATION OF HPLC PROCEDURE FOR DETERMINATION OF GOSSYPOL IN THE SUBSTANCE KAGOCEL

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DOI: https://doi.org/None
Issue: 
8
Year: 
2016

I.V. Kiseleva (1); Professor B.A. Rudoy (1), PhD; Professor A.V. Pirogov (2), PhD; N.G. Tolmacheva (2) 1 -OOO «NIARMEDIK PLYUS»; 12, Aircraft Designer Mikoyan St., Moscow 125252, Russian Federation 2 -Faculty of Chemistry, M.V. Lomonosov Moscow State University; 1, Leninsky Gory, Build. 3, GSP-1, Moscow 119991, Russian Federation

Introduction. The molecules of gossypol, a natural polyphenolic compound present in the cotton plant, are used to synthesize the antiviral drug Kagocel®. The higher dose of gossypol may exhibit toxic properties. Each batch of the produced substance must be necessarily checked for free gossypol content in the final product. Objective: To conduct validation studies of the developed HPLC procedure for determining the impurities of free gossypol, which should be included in a quality control system when manufacturing the pharmaceutical substance Kagocel. Material and methods. The pharmaceutical substance Kagocel was an investigation subject. Gossypol impurities were determined using high performance liquid chromatography (HPLC) with spectrophotometric detection. Results. The highly sensitive and specific HPLC procedure for determining free gossypol in the substance Kagocel was validated in accordance with the current pharmacopoeial requirements. All validation parameters meet the acceptance criteria. Conclusion. The procedure can reliably detect, with a high degree of accuracy, free gossypol impurities being more than 1.56·10-5 mg/ml.in the substance Kagocel.
Keywords: 
gossypol
Kagocel
high performance liquid chromatography
validation
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