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

H K Sundeep Kumar,Si, Abhik,Suman Acharyya

doi:10.9734/jpri/2021/v33i43a32516

Abstract

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.

Highlights

Mucormycosis, formerly known as zygomycosis and better known as black fungus, refers to a group of diseases caused by fungi belonging to the Mucorales order
Various UPLC chromatographic settings were attempted in order to find the best method for estimating isavuconazole in API and capsule format
Using a mobile phase of methanol and phosphate buffer (60:40) and a flow rate of 0.4 mL / min, isavuconazole was eluted with excellent peak shape and low retention time

Summary

Introduction

Mucormycosis, formerly known as zygomycosis and better known as black fungus, refers to a group of diseases caused by fungi belonging to the Mucorales order. As of May 25, 2021, more than 11,700 people in India were being treated for mucormycosis as a result of the COVID-19 pandemic, according to the Indian government. 3-(2,5-difluorophenyl)-3hydroxy-4-(1,2,4-triazol-1-yl)butan-2-yl]-1,3thiazol-4 yl] benzonitrile (CAS 241479-67-4), is its chemical name (Fig. 1) It acts by preventing the formation of fungal cell membranes. It is evident that only one RP-HPLC method for estimating isavuconazole in bulk and formulation was available. In light of the aforementioned drawbacks, a quick, specific, reliable, and validated stability indicating method for this analyte must be developed and reported. The current research task aimed to eliminate all drawbacks and develop a fast, stability-indicating UPLC method for estimating isavuconazole in bulk drugs and capsule dosage forms, and a validation study, in compliance with the International Conference on Harmonization (ICH) Guidelines Q2 (R1) [11]

Methods

Results

Conclusion