Abstract

A selective and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Ospemifine. 10 mg of Ospemifine was dissolved in mobile phase. The solution was scanned from 200-400 nm the spectrum was obtained. The overlay spectrum was used for selection of wavelength for Ospemifine. The isobestic point was taken as detection wavelength. The separation was good, peak shape was good, so we conclude that there is no required for decrease the retention times of peak, so it is taken as final method. Mix a mixture of 40 ml water (40%) and 60 ml of Acetonitrile (60%) and degassed in ultrasonic water bath for 5 minutes. Filter through 0.22 μ filter under vacuum filtration.10 mg of Ospemifine working standard was accurately weighed and transferred into a 10 ml clean dry volumetric flask and add about 2 ml of diluent and sonicate to dissolve it completely and make volume up to the mark with the same solvent (Stock solution).Further pipette out 1.0 ml from the above stock solution into a 10 ml volumetric flask and was diluted up to the mark with diluent. The chromatographic method development for the estimation of Ospemifine were optimized by several trials for various parameters as different column, flow rate and mobile phase, finally the following chromatographic method was selected for the separation and quantification of Ospemifine in API and pharmaceutical dosage form by RP-HPLC method. The retention time of Ospemifine was found to be 2.425 mins. The system suitability parameters for Ospemifine such as theoretical plates and tailing factor were found to be 4146, 1.2.The % purity Ospemifine in pharmaceutical dosage form was found to be 99.56%.

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