Development of procedure for quantitative determination of triterpenoids and phytosterols in capsules with Sabal palm fruit extract

Introduction. Analysis of the pharmaceutical market shows that in the treatment of chronic prostatitis drugs containing Sabal palm fruit extract are used. During the research we developed a domestic analogue of the registered medicinal product containing this extract. In preparation of the regulatory documentation and registration dossier for the new drug, we carried out the research necessary for this purpose on the Sabal palm fruit, biologically active extract and soft gelatin capsules. Objective of the study. Development and validation of the methodology for quantitative determination of triterpenoids and phytosterols in capsules containing Sabal palm fruit extract. Material and methods. The objects of the study are pilot series of a medicinal product with the extract of palm Sabal fruit – soft gelatin capsules 160 mg/caps. and 320 mg/caps. The method underlying the determination of the sum of triterpenoids and phytosterols – differential spectrophotometry Results and discussion. The pharmacological activity of Sabal palm fruit extract is associated with lipids, namely higher fatty acids, triterpenoids and phytosterols. The methodology of standardization of the new drug was developed taking into account their physico-chemical properties. The analysis provides alkaline hydrolysis, selective extraction of the unsaponifiable fraction, differential spectrophotometry after oxidation of sterols in the presence of sulfuric acid. The content of the analyzed substances in the drug: for dosage of 160 mg/caps. – not less than 5.5 mg/cup, for the dosage of 320 mg/cup. – not less than 11.0 mg/caps. in terms of β-amyrin. Conclusion. The methods for quantitative determination of the sum of triterpenoids and phytosterols in a new drug preparation containing an extract of Sabal palm fruit have been developed, validated and tested. In the course of approbation of the method the norms of their quantitative content in the medicinal product were experimentally established. The method complies with all validation criteria, is characterized by ease of performance and can be used for standardization and quality control at all stages of industrial production of the medicinal product.