EXTRACTIVE SPECTROPHOTOMETRIC METHOD DEVELOPMENT & VALIDATION FOR DETERMINATION OF ISAVUCONAZOLE
Manoj Kumar, Mr. Sarfaraz Ahmad, Mr. Jogender Singh, Mr. Murari Lal, Dr. Avinash Krishnrao Kondalkar
ABSTRACT
A simple, accurate, exact, and rapid extractive spectrophotometric approach was devised for the measurement of Isavuconazole in tablets and biological fluids. Various analytical parameters have been evaluated and the results have been validated by statistical data. It was observed that the drug only reacted with Bromocresol Green. Further the ?max of IVZ was found to be 506.0 nm. The Linearity of IVZ At ?max of 506nm estimated the Correlation Coefficient (r2) as 0.999 with slope as 0.028. Form the results of recovery study it was clearly observed that % recovery at 80%, 100% & 120% as 97.96±1.172, 99.08±0.834 & 99.38±0.469 respectively. The repeatability & reproducibility was observed to be 99.127±0.064 and 99.666±0.039 respectively while the day to day & Analyst to Analyst variation was noted to be 99.530±0.038 and 99.450±0.150 respectively. The assay of tablet formulation in replicate 1 was performed The Conc. found (µg/ml) ranged between196.65 to 198.85. The % Conc. Found was observed to be varied from 98.33 to 99.56. The Mean, SD & % RSD values was observed to be 99.21, 0.501 and 0.505 respectively. The proposed method has been used to identify the Isavuconazole in various medicinal goods with success. The suggested approach is suited to quantify Isavuconazole in pharmaceutical formulations, as shown by the good agreement between extractive spectrophotometric method and high-performance liquid chromatography mass spectrometry (HPLC-MS) for the determination of Isavuconazole in various genuine samples
[Full Text Article]