HPLC Method Development and Validation: For Simultaneous Determination of Flibanserin and Caffeine

A simple and rapid HPLC method is developed and validated for the simultaneous determination of Flibanserin and Caffeine. This is the first single reported method for these two drugs. The good separation was achieved by HPLC technique using 0.1% ammonium acetate buffer (pH 3) and ACN as the mobile phase, a C18 column and wavelength set at 254nm. The retention time for Caffeine and Flibanserin is 2.0 min and 4.9 min respectively. The method was validated as per ICH guidelines for linearity, precision, accuracy, LOD, LOQ, robustness and solution stability. The method shows good accuracy and precision with RSD value of less than 2%. The Flibanserin shows good linearity in range 50.0μg-150.0μg/mL and Caffeine in range 10.0μg-30.0μg/ mL.