Sierra PRC, Rodríguez LEA, Vicente MR, Marrero DD, González CVL, Morales RCL

Language: Spanish
References: 15
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ABSTRACT

Introduction: an appropriate dosage of the substances to be evaluated in toxicological studies should be ensured. It is necessary a method for the analysis of the aqueous emulsions used for the administration of D-004, an active ingredient obtained from the royal palm (Roystonea regia). This product could have a potential use in the treatment of benign prostatic hyperplasia.
Objective: to develop a method for the quantification of D-004 in emulsions with doses between 10 and 500 mg/mL and to determine the stability of such emulsions.
Methods: the active ingredient was extracted with a solution of the acid C_13:0 (internal standard) in n-hexane .Then it was analyzed by gas chromatography, after the conversion of the fatty acids into methyl esters. The method, validated according to ICH guides, was used for determining the stability of D-004 emulsions, stored in clear glass flasks, at 25 ± 2 °C and 60 ± 5 % relative humidity.
Results: the analytical method met the validation criteria and allowed to determine that D-004 emulsions have a shell life of seven days under the conditions and the container employed in the study.
Conclusions: the present analytical gas chromatography method, developed and validated in this study, can be used for quality control and stability study of emulsions of D-004 between 10 and 500 mg/mL.

REFERENCES

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