Development and validation of stability indicating RP-HPLC method for the determination of ezetimibe in pharmaceutical dosage forms

In the present study, a simple, rapid and precise liquid chromatographic method was developed and validated for the determination of ezetimibe in its dosage form. Ezetimibe was separated in a 100 x 4.6 mm i.d., C18 column, 3 um particle size, Luna phenomenex, using a mobile phase composition of water and acetonitrile (60:40 v/v). Column oven temperature was kept at 25 °C. The flow rate was 1.5 mL/min and the analyte monitored at 225 nm. The retention time of Ezetimibe was 8.47 min. The specificity of the method was determined by assessing interference from the placebo and by stress testing of the drug (forced degradation).The developed method was validated in terms of linearity, accuracy, precision, system suitability, limit of detection, limit of quantitation and solution stability. The proposed method was also applied successfully to the pharmaceutical dosage form self emulsified drug delivery without any interference by excipients.Colegio de Farmacéuticos de la Provincia de Buenos Aire

Cyclosporine A-Nanosuspension: Formulation, Characterization and In Vivo Comparison with a Marketed Formulation

Cyclosporine A-nanosuspensions were prepared using zirconium oxide beads as a milling media, Poloxamer 407 as a stabilizer and distilled water as an aqueous medium using the Pearl Milling technique. The optimized formulation was characterized in terms of particle size distribution, surface morphology, drug-surfactant interaction, drug content, saturation solubility, osmolarity, and stability. The nanoparticles consisting of Poloxamer-bound cyclosporin A with a mean diameter of 213 nm revealed a spherical shape and 5.69 fold increased saturation solubility as compared to the parent drug. The formulation was found to be iso-osmolar with blood and stable up to 3 months at 2–8°C. In-vivo studies were carried out in albino rats and the pharmacokinetic parameters were compared with a marketed formulation, which indicated better results of the prepared formulation than the marketed one