For the determination of the assay of voriconazole in bulk and in pharmaceutical dosage forms, a novel stability indicating RP-HPLC method was designed and validated, exhibiting a very low run time. The stability-indicating nature of the approach is supported by the fact that it is unique, quick, precise, accurate, and capable of isolating the voriconazole peak from any contaminating or degrading components. Isocratic elution on a 100 mm x 4.6 mm, 3μm agilent C18 column at 45°C and a UV detection wavelength of 256 nm constitutes the analytical procedure at at a flow rate of 1.0 mL/min. After injecting 20µL of voriconazole sample, the elution peak occurred at 3.5 minutes, and the entire run time was 15 minutes. Between 98% and 102% was a reasonable range for the percentage of recovery. It was determined that the method's RSD for precision and accuracy was less than 2%. The method has been verified for routine analysis of voriconazole in bulk materials and its formulations according to the standards established by the International Conference on Harmonization (ICH).
For the determination of the assay of voriconazole in bulk and in pharmaceutical dosage forms, a novel stability indicating RP-HPLC method was designed and validated, exhibiting a very low run time. The stability-indicating nature of the approach is supported by the fact that it is unique, quick, precise, accurate, and capable of isolating the voriconazole peak from any contaminating or degrading components. Isocratic elution on a 100 mm x 4.6 mm, 3μm agilent C18 column at 45°C and a UV detection wavelength of 256 nm constitutes the analytical procedure at at a flow rate of 1.0 mL/min. After injecting 20µL of voriconazole sample, the elution peak occurred at 3.5 minutes, and the entire run time was 15 minutes. Between 98% and 102% was a reasonable range for the percentage of recovery. It was determined that the method's RSD for precision and accuracy was less than 2%. The method has been verified for routine analysis of voriconazole in bulk materials and its formulations according to the standards established by the International Conference on Harmonization (ICH).
Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.
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