|
INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
Imp Links for Author
Imp Links for Reviewer
Research Area
Subscribe IJSDR
Visitor Counter
Copyright Infringement Claims
Indexing Partner
|
Published Paper Details
|
|
| Paper Title: | STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CRISABOROLE IN BULK DRUGS BY USING UPLC |
| Authors Name: | Syed Mastan Ali , D. Ramachandran |
| Unique Id: | IJSDR2105022 |
| Published In: | Volume 6 Issue 5, May-2021 |
| Abstract: | 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. |
| Keywords: | Crisaborole, stability indicating UPLC method, Assay validation. |
| Cite Article: | "STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CRISABOROLE IN BULK DRUGS BY USING UPLC", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.6, Issue 5, page no.122 - 129, May-2021, Available :http://www.ijsdr.org/papers/IJSDR2105022.pdf |
| Downloads: | 000337067 |
| Publication Details: | Published Paper ID: IJSDR2105022 Registration ID:193293 Published In: Volume 6 Issue 5, May-2021 DOI (Digital Object Identifier): Page No: 122 - 129 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
|
Click Here to Download This Article |
|
| Article Preview | |
|
|
|
Major Indexing from www.ijsdr.org
| Google Scholar | ResearcherID Thomson Reuters | Mendeley : reference manager | Academia.edu |
| arXiv.org : cornell university library | Research Gate | CiteSeerX | DOAJ : Directory of Open Access Journals |
| DRJI | Index Copernicus International | Scribd | DocStoc |
Track Paper
Important Links
Conference Proposal
ISSN
 |
 |
DOI (A digital object identifier)
  Providing A digital object identifier by DOI How to GET DOI and Hard Copy Related |
Open Access License Policy
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
|
 |
 |
 |
Social Media
Indexing Partner |
|||
| Copyright © 2024 - All Rights Reserved - IJSDR | |||
Facebook Twitter Instagram LinkedIn