Study of compliance of some pharmaceutical formulations of ibuprofen with international standards

Author: Ana Tavartkiladze
Keywords: Ibuprofen, Enantioseparation, High Performance Liquid Chromatography, Polysaccharide based chiral stationary phases, Enantiomer elution order, Active pharmaceutical ingredient, Compliance with international standards
Annotation:

Ibuprofen is a nonsteroidal, anti-inflammatory drug with analgesic and antipyretic properties. It is a chiral compound with two enantiomers. Pharmaceutical activity of ibuprofen is related to its S (+) enantiomer, however in the body of mammalians inactive R(-) enantiomer undergoes inversion and is transformed into S(+) form. Two enantiomers of ibuprofen have different pharmacology. The differences between the enantiomers raise more interest in thorough and comprehensive research of their individual properties and at the same time development of proper separation methods. The objective of the work was study of active pharmaceutical ingredient (API) in some pharmaceutical formulation of ibuprofen. Quantitative determination of total, as well as individual enantiomeric content of ibuprofen and assessment of compliance with international standards. Prerequisite for the implementation of the purpose of the study was development of liquid chromatographic method, by using which efficient and fast separation of enantiomers of ibuprofen would be achieved and in addition to this, enantiomer elution order would be acceptable. At the first stage of work effectiveness of different polysaccharide based chiral columns under different mobile phases were examined in terms of separation of ibuprofens of enantiomers. From the satisfactory results achieved the most admissible, optimal one was selected for the analytical method validation. At the final step of the work the drugs of racemate and pure enantiomeric ibuprofens were analysed. The compliance with international standards was studied. All of the drug tested met the norms of total active pharmaceutical ingredient. However, non-compliance with standards was detected in dexibuprofen drug with regards to impurity content, percentage of impurity in enantiomerical pure drug was higher than 0.1%.