NEW STABILITY INDICATING METHOD FOR ESTIMATION OF PURITY OF FLIBANSERIN ACTIVE PHARMACEUTICAL INGREDIENT

Flibanserin has been recently approved by the USFDA for treating female sexual interest disorder. It is currently not included in any of the Pharmacopoeias. No stability indicating method information about flibanserin has been reported in the literature. Flibanserin stock solution (1 mg/mL) was prepared and serially diluted (concentration ranged 1-20 μg/mL). Flibanserin solutions (1-20 μg/mL) were analysed using RP-HPLC under isocratic elution of mobile phase acetonitrile and ammonium acetate (60:40; V/V) at 1 mL/minute. This HPLC method was validated for linearity, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ), according to ICH guidelines. Results showed that the method developed has promising linearity (r2= 0.9993), accuracy, precision (0.92-1.61%), robustness, LOD and LOQ. The developed HPLC method for evaluation of flibanserin was found reliable, precise, sensitive, accurate and repeatable for routine analysis and quality control of flibanserin. It is suitable to be used as stability indicating method in pharmaceutical analysis.