Development and Validation of Stability Indicating RP-HPLC Method for Fluvoxamine Maleate

Abstract

A new, simple, accurate, precise, rapid and selective stability indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for quantification of Fluvoxamine Maleate from its tablet dosage formulation. The method is based on reverse phase chromatography using Phenomenex Luna C8 (150mm x 46mm, 5μ particle size column. The separation in all the degradation peaks were achieved by using gradient elution of 20 mM KH2PO4(pH-3) and Acetonitrile at flow rate 1.0 mL/min and UV detection at 234 nm with the total run time of 40 min. The column is maintained at 30°C throughout the analysis. Stability indicating capability is established by forced degradation experiment of Fluvoxamine Maleate to acid, alkali, neutral, oxidation, thermal and photodegradation conditions according to ICH guidelines. The peaks of degradation samples were found to be very pure with complete resolution. The linear regression analysis data for the calibration plots showed a very good linear relationship with concentration range of 0.05- 750μg/mL with the linearity equation of y = 99507x + 64401(r2 = 0.9999). The method is validated for specificity, accuracy, precision, linearity, and robustness, limit of detection and limit of quantification as per ICH guidelines. The limit of detection and quantitation were found to be 0.015μg/mL and 0.05μg/mLrespectively. Additionally, a mass-compatible method for LC/MS instrument is also developed for the Characterization of different degradation peaks formed during the forced decomposition studies. The degradation behavior was found to be similar in case of Fluvoxamine Maleate API and its marketed dosage form with the % assay value of 98.22%. So, the developed RP-HPLC method can also be applied for the estimation of Fluvoxamine Maleate from its dosage form. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating assay method.