A Stability Indicating Novel UPLC-PDA Method for the Estimation in Bulk and Capsule Dosage form of Isavuconazole Effective for Mucormycosis Caused by COVID-19 Pandemic
Journal of Pharmaceutical Research International,
The present research provides a new proven ultra-high-performance liquid chromatographic technique for isavuconazole in both bulk and capsule dosage forms. DIKMA Waters BEH C18(50 x 2.6mm, 1.7m) column was used for chromatographic separation. With the isocratic elution mode, a mixture phosphate buffer: methanol 40:60 v/v, was used as the mobile phase, and the eluent was measured at 253 nm using a UV detector. The strategy has been maintained and validated in accordance with the International Conference on Harmonization Guidelines. Stressed deterioration has also been investigated in acidic, alkaline, peroxide, thermal, and photolytic conditions. Isavuconazole was eluted with the retention time 0.861 minute in this procedure. The calibration curve plots for isavuconazole were found to be linear within the concentration ranges of 1-25µg/mL. With a percentage recovery of 100.18 percent, the limit of detection was 0.025g/ml and the value for limit of quantification was 0.50µg/mL. In a force degradation analysis, the current approach was also determined to be stable. Based on the experiential evidence, the present method was found appropriate of isavuconazole estimation in the form of bulk and capsule.
- method development
- method validation
- ICH guidelines
How to Cite
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