Validation of an analytical method for quality control of residual solvents (n-hexane and acetone) in D-002: new active ingredient from beeswax.

Abstract

D-002 is a new natural product consisting of a mixture of aliphatic fatty alcohols, which shows antioxidant and anti-ulcer effects in experimental models. A new validated methodology for determining simultaneously residual n-hexane and acetone in D-002 using the headspace gas chromatography (HS/GC) is described. The very poor solubility of D-002 in most solvents did necessary sample preparations in solid state. Limit test conditions allowed a detection of residual n-hexane and acetone more sensitively than that recommended for such purposes in the general method of the European Pharmacopoeia. Validation assays, applied to both D-002 residual solvents, proved: suitable sensitivity; very high linearity (correlation coefficients > or =0.999, R.S.D. of slopes < or =0.8% and R.S.D. of response factors < or =5% and no biases) and accuracy (average recoveries between 94.7 and 100.1%); and precision was < or =2.1%. The method was found suitable for quality control and stability studies of this new product.

• Authors: Ernesto Méndez Antolín, Yaisme Balcinde Quiñónez, Víctor González Canavaciolo, Esperanza Rodríguez Cruz
• Journal: Journal of pharmaceutical and biomedical analysis (J Pharm Biomed Anal) Vol. 47 Issue 3 Pg. 646-50 (Jul 15 2008) ISSN: 0731-7085 [Print] England
• PMID: 18462903 (Publication Type: Journal Article, Validation Study)

Chemical References

• D 002
• Fatty Alcohols
• Hexanes
• Solvents
• Acetone
• n-hexane

Topics

• Acetone (analysis)
• Chromatography, Gas
• Fatty Alcohols (analysis, standards)
• Hexanes (analysis)
• Quality Control
• Solvents (analysis)