STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CRISABOROLE IN BULK DRUGS BY USING UPLC
Syed Mastan Ali
, D. Ramachandran
Crisaborole, stability indicating UPLC method, Assay validation.
The validated analytical method was applied for the estimation of Crisaborole(CRB) by reverse phase ultra-performance liquid chromatography (RP-UPLC). The drug was subjected to various stress Conditions such as hydrolysis, oxidation, photolytic and thermal degradations to investigate the stability indicating ability of the method. Compound is highly sensitive against hydrolytic stress conditions like basic and oxidative stress conditions. In oxidative condition product completely converted into degradation product with boron ring got opened. Efficient chromatographic separation was achieved by using Acquity; UPLC, CSH; C-18; 100 x 2.1mm; 1.7 µm column with the mobile phase consisting of 0.1% Trifluoro acetic acid in water and 0.1% Trifluoro acetic acid in acetonitrile in a gradient elution mode within a short run time of 6.0 minutes at a flow rate of 0.4 ml/min with column temperature at 25°C. The developed method was validated as per the current ICH quality guidelines with respect to specificity, precision, accuracy, linearity, robustness and solution suitability. The average recovery values of Crisaborole were found to be in the range of 100.05-101.16 %. The developed method was linear with the correlation value of 0.9995 for Crisaborole. The repeatability and intermediate precision expressed by RSD were less than 2.0% for Crisaborole. The test solution was found to be stable in diluent for 72 h when stored at room temperature. The developed UPLC method is superior in technology against conventional HPLC with respect to speed, resolution, solvent consumption and cost of analysis. This method is compatible to LCMS analysis which enables to identify the unknown impurities or the degradants formed in the process.
"STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CRISABOROLE IN BULK DRUGS BY USING UPLC", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.6, Issue 5, page no.122 - 129, May-2021, Available :https://ijsdr.org/papers/IJSDR2105022.pdf
Volume 6
Issue 5,
May-2021
Pages : 122 - 129
Paper Reg. ID: IJSDR_193293
Published Paper Id: IJSDR2105022
Downloads: 000347308
Research Area: Chemistry
Country: Hyderabad, Telagana, India
ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJSDR(IJ Publication) Janvi Wave
