Development & Validation of Stability Indicating Assay Method for Quantitative Estimation of FLIBANSERIN in Solid Dosage Form by RP-HPLC

Abstract

A new, simple, precise, accurate, fast and selective stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated from its tablet dosage formulation for quantification of Flibanserin drug. Method is based on the Reverse phase chromatography using Inertsil ODS 3V (250× 4.6 mm), 5 μm particle size column. Separation was achieved in all degradation peaks using isocratic elution (1 ml Tri fluoro acetic acid in 1000 ml of Milli Q water) Buffer solution: Acetonitrile in Ratio of 60:40% v/v at flow rate 1.2 mL / min and UV detection at 250 nm with a total runtime of 15 min. column temperature is 30 °C throughout the analysis. Forced degradation experiment of Fluvoxamine Maleate to acid, alkali, neutral, oxidation, thermal and photo degradation conditions in accordance with ICH guidelines establishes stability indicating capacity. The method is validated in accordance with ICH guidelines for specificity, accuracy, accuracy, linearity and robustness, detection limit and quantification limit. The linear regression analysis data for the calibration plots showed a very good linear relationship with concentration range of 50-150 μg/mL with the linearity equation of y = 15.691x + 14.052 (r2 = 0.9998). The RP-HPLC method developed may also be used to estimate Flibanserin from its dosage form. Since the method could effectively separate the drug from its products of degradation, it can be used as a stability indicating assay method.