FORCE DEGRADATION STUDY AND RP-HPLC METHOD DEVELOPMENT FOR ESTIMATION OF FLUVOXAMINE MALEATE IN TABLET
Keywords:
HPLC, Fluvoxamine maleate (FLV), Forced Degradation, Validation, Stability indicatingAbstract
Objective: To evaluate stability of drug by force degradation studies and to develop validated RP-HPLC method for quantitative estimation of fluvoxamine maleate in pharmaceutical dosage form.
Methods: The optimized chromatographic conditions utilizes reversed-phase C18 Hyperchrome ODS column (250X4.6 mm, 5µ), mobile phase comprised of Methanol and Phosphate buffer (pH-2.5) in the ratio of 70:30 v/v, flow rate of 1 ml/min at ambient temperature and UV detection at 250 nm.
Results: In the proposed method the retention time of fluvoxamine was found to be 5.94 min. The linearity of the proposed method was tested in the range of 10-50 μg/ml and correlation coefficient was found to be 0.998. The accuracy of the proposed method was carried out by standard addition method and found to be 99.62%. The % RSD of precision study was calculated as 0.69. The standard and marketed formulation exposed to hydrolytic and oxidative stress conditions indicates significant degradation with good resolution between the peaks corresponds to degradation products and analyte. The proposed force degradation study shows that fluvoxamine is labile molecule to acid, alkali, neutral and oxidative conditions and also susceptible to degradation when exposed to UV light, and humidity conditions while it was stable under dry heat (50 °C).
Conclusion: The proposed validated HPLC method for the quantitative estimation of fluvoxamine maleate in tablet dosage form is accurate, precise, economic, and robust. The developed stability indicating method can be recommended for analysis of drug and its degradation products in stability samples.
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