DEVELOPMENT AND VALIDATION OF A DISSOLUTION METHOD FOR FROVATRIPTAN TABLETS BY REVERSED PHASE UPLC
Keywords:
Frovatriptan (FRT) tablets, RP-UPLC method, Development and validationAbstract
Objective: The main objective of the method was to develop a simple, rapid, efficient and reproducible, stability indicating reverse phase ultra performance liquid chromatography (RP-UPLC) method for the estimation of frovatriptan in tablet dosage form.
Methods: The RP-UPLC method for estimation of frovatriptan (FRT) in their tablets was carried out on Acquity UPLCTM, BEH C-18 (100 × 2.1 mm, 1.7 µm) column using 0.1% trifluroacetic acid buffer and a mixture of methanol and acetonitrile (50:50) using isocratic program. The flow rate of the mobile phase was 0.2 mL min-1and detection wavelength was carried out at 244 nm. Total runtime is 3 minutes for chromatographic run. The method was validated in terms of specificity, linearity, accuracy, precision and robustness as per ICH guidelines.
Results: The method was found to be linear in the range of 1.41-3.67 μg mL-1. Recovery was found to be in the range of 97.8-101.8%. Relative standard deviation for precision and intermediate precision was found to be less than 3%. The developed method was successfully applied for the estimation of frovatriptan in tablet formulation and average dissolution rate was found to be 93%. The results obtained from the validation experiments prove that the developed method is suitable for routine analysis.
Conclusion: The developed RP-UPLC method was simple, rapid, accurate, and precise for the estimation of dissolution rate in frovatriptan tablet dosage form.
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References
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