(Meth)acrylic Microparticles Containing Piperine: Development and Validation of an RP-UHPLC-DAD Method for Assessing the Drug-loading Efficiency and the In vitro Drug Release

Piperine (PIP) is an alkaloid found in pepper species that has been widely used due to its antioxidant, cytoprotective, and potential pharmacological effects in obesity. However, novel drug delivery system containing PIP requires the validation of an appropriate analytical method for its quality control during the research and development process in the pharmaceutical industry. In this context, this paper was firstly devoted to preparing PIP-loaded Eudragit S100 and Eudragit RS30D microparticles by the spray drying method. A reversed phase ultra-high performance liquid chromatography coupled to diode array detection (RP-UHPLC-DAD) method was then developed and validated as per International Council for Harmonization guidelines for quantifying the drug loaded and released from dissolution experiments. The analytical method demonstrated to be specific, linear (r = 0.9999), precise, accurate, and robust in a range of 0.5 to 50.0 mu g/mL. The drug encapsulation efficiency varied between 66.36 and 90.15%. Pure PIP presented an immediate release profile, while Eudragit microparticles provided extended and delayed drug release profiles. The RP-UHPLC-DAD method was successfully developed and validated for performing the quality control of Eudragit S100 and Eudragit RS30D microparticles containing PIP during the drug quantification and drug dissolution stages.